MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; HIP FEMORAL STEM

Catalog Number	157011110
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unspecified Mental, Emotional or Behavioural Problem (4430); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Pinnacle metal on metal litigation form received.Litigation alleges pain in hip, metallosis, elevated levels of cobalt and chromium, soft tissue damage, a corrective surgery to remove the defective product and other painful injuries.Doi: (b)(6) 2011.Dor: unknown.Affected side: unknown side of hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Added: d10 concomitant.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Updated event description: patient was revised due to degenerative pain, soreness, difficulty walking, and significantly elevated cobalt and chromium levels with a large pseudotumor and abductor and soft tissue compromise including necrosis.Doi: (b)(6) 2011.Dor: (b)(6) 2022.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: a1,a2,a4,b3, b5, b6, b7, h4, h6 health effect clinical code and medical device problem code.Corrected: d1, d2a.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received and states that: in addition to what was previously alleged.Litigation alleges soreness, difficulty walking, pseudotumor, abductor and soft tissue compromise and necrosis.It was also reported that the patient experienced mental anguish, discomfort, emotional distress and limited adl.After review of medical records the patient was revised to address hip pain, elevated metal ion, large pseudotumor, edema, abductor and soft tissue compromise, metallosis and adverse tissue reaction.Operative note reported large amount of clear slightly green stain fluid consistent with a pseudotumor, trochanter was essentially bald, necrotic material present, posterior capsular scar present.The cup was noted to be slightly vertical and corrosion at the taper.Debrided some anterior capsule and some osteophyte on the anterior column.Doi: (b)(6) 2011; dor: (b)(6) 2022 ; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary no device associated with this report was received for examination.Product description: - summit por taper sz5 hi off product code: - 157011110 lot no: - e64c41 quantity of manufactured: - 10 date of manufacturing: - nov-2010 expiry date: - nov-2020.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot product description: - summit por taper sz5 hi off product code: - 157011110 lot no: - e64c41 quantity of manufactured: - 10 date of manufacturing: - nov-2010 expiry date: - nov-2020.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5, b6, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records were reviewed by a clinician.Patient received a right depuy pinnacle/trilock cop tha via anterior approach on (b)(6) 2018.The procedure was completed without complications.No further information was provided.(b)(4) was created to capture right hip surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added : b7.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b7 and d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: pinnacle metal on metal litigation form received.Litigation alleges pain in hip, metallosis, elevated levels of cobalt and chromium, soft tissue damage, a corrective surgery to remove the defective product and other painful injuries.The product was not returned to depuy synthes, however photos were provided for review.See attachment "photos retrieved from disc".The x-ray investigation revealed nothing indicative of a device non-conformance.No defects on the summit por taper sz5 hi off that could have contributed to the reported event was observed.A manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the summit por taper sz5 hi off would have not contributed to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device e64c41 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review- a manufacturing record evaluation was performed for the finished device e64c41 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Recaptured codes on h6.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected: d6b.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20086002
• Report Number: 1818910-2024-18225
• Device Sequence Number: 7580790
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: (01)10603295060062(17)201126(10)E64C41
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2020
• Device Catalogue Number: 157011110
• Device Lot Number: E64C41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 10/09/2024; 05/06/2025; 05/21/2025; 07/10/2025; 08/07/2025; 09/25/2025; 11/05/2025; 11/18/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/03/2024; 10/15/2024; 05/15/2025; 05/22/2025; 07/18/2025; 08/19/2025; 09/29/2025; 11/13/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +1.5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White