MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,22X17X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3422

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Arrhythmia (1721); Dyspnea (1816); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); Paresthesia (4421); Limb Fracture (4518); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Litigation record alleges that patient have experienced pain, discomfort, shortness of breath, walking difficulty, heart palpitation, reduced mobility, metallosis, psychological and emotional injuries, adverse tissue reaction around the hip, and elevated cobalt and chromium levels but lab results are 3.9mcg and 1.5 mcg.Doi: (b)(6) 2005 dor: (b)(6) 2020 right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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 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 Description

In addition to what were previously alleged, litigation reported that the plaintiffs revision involved, in part, a finding of an adverse tissue reaction related to the metal-on-metal articulation, release of a large amount of brownish fluid, and debridement and removal of brownish friable tissue throughout the entire hip joint, all due to toxic heavy metal/metal ion cobalt and chromium poisoning.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> update 9-june-2022 no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
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> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Patient was revised to address metal-on-metal articulation with adverse tissue reaction.Heterotopic bone and chronic fragmentation of the lesser trochanter of the right were noted.Patient had small fracture about the lesser trochanter at the right hip.Patient had right tibial plateau fracture.Patient's pain tend to be worse when initially stands from a seated position and have occasional numbness in lower extremities and right lower extremity paresthesia.There is fluid collection at the trochanteric bursa with a thickened rim and internal debris consistent pseudotumor.Revision notes stated that there was large amount of friable brownish gray tissue enveloping the entire hip joint.It notes there was a broken internal right hip prosthesis, subsequent encounter (primary).It is unclear what this pertains to, as radiographs from (b)(6) 2022 are reported to show there is chronic fragmentation of the lesser trochanter of the right hip.There are no acute fracture or hardware-related complications.The patient did report right hip pain.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.X-ray evidence provided was reviewed and found no visible implant issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.X-ray evidence provided was reviewed and found no visible implant issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

After review of the medical records, clinical visit reported right thigh/groin pain, weakness extension of knee and flexion of hip, concerning for muscle, tendon, and tear injury, lightheadedness, eczema, anxiety and depression.Mri showed pseudotumor.Scanned showed incompletely healed fracture in tibia.Comminuted lateral tibial plateau fracture with at least 3 mm of persistent depression and residual fragmentation.Fractured being treated nonoperatively with closed treatment initiated on (b)(6)2018.Fractured due to patient fell off from a roof on (b)(6)2019.Patient is limping, bruises and had hip pain.Lab result for metal ions is below 7ppb.Doi: (b)(6)2005.Dor: (b)(6)2020.Affected side: right hip.

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.

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.H10 additional narrative: added: b6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.X-ray evidence provided was reviewed and found nothing indicative of an implant issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: product code 523422, work order 1824500 was manufactured on 02-nov-2004.12 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot device history review: product code 523422, work order 1824500 was manufactured on 02-nov-2004.12 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11814330
• MDR Text Key: 250330214
• Report Number: 1818910-2021-10153
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171058
• UDI-Public: 10603295171058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: 52-3422
• Device Catalogue Number: 523422
• Device Lot Number: 1824500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 11/18/2021; 06/09/2022; 12/05/2022; 01/18/2023; 01/27/2023; 02/13/2023; 03/29/2023; 06/07/2023
• Supplement Dates FDA Received: 05/19/2021; 11/24/2021; 06/09/2022; 12/12/2022; 01/19/2023; 02/01/2023; 02/13/2023; 04/12/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD; S-ROM M HEAD 36MM +6; S-ROM*SLEEVE PRX ZTT, 22B-LRG; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL SLEEVE SROM; UNK HIP FEMORAL SLEEVE SROM; UNK HIP FEMORAL STEM SROM; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG