MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Pinnacle metal on metal hip medical records received.After review of the medical records the patient was revised to address metallosis, right hip pain, elevated cobalt and chromium level and large pseudocyst.Operative note reported debriding of soft tissues that showed significant metallosis.Note significant debris along the deep portions of the capsule.Lab result shows cobalt and chromium level were above 7 ppb.(b)(6); right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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 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.

• Brand Name: SUMMIT POR TAPER SZ4 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18282737
• Report Number: 1818910-2023-24850
• Device Sequence Number: 6762010
• Product Code: LPH
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 12/18/2016
• Device Catalogue Number: 157011100
• Device Lot Number: A88C91000
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2006
• 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 +8.5; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White