MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157001120
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a failed left total hip replacement surgery due to articular bearing wear, elevated cobalt levels and an adverse reaction to articular wear.Intraoperative findings described moderate clear effusion with brown staining and debris of the inner lining.Pseudomembrane was stained and debris was debrided.After removal of the head, there was considerable black corrosion debris at the bunion edge consistent with failure of the asr.Doi: (b)(6) 2009, dor: (b)(6) 2024, left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.E3 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.According to the information received, ¿patient had a failed left total hip replacement surgery, acticular bearing wear.Elevated cobalt levels and adverse reaction to articular wear.Moderate clear effusion with brown staining and debris of the inner lining.Pseudomembrane was stained and debris was debrided.After removal of the head, there was considerable black corrosion debris at the bunnion edge oonsistent with failure of the asr.Doi: (b)(6) 2009, dor: (b)(6) 2024, left hip¿.Product description: - summit por taper sz6 std off product code: - 157001120 lot no: - dv6kd1 quantity of manufactured: - 10 date of manufacturing: - may-2009 expiry date: - may-2019.A manufacturing record evaluation was performed for the finished device product description: - summit por taper sz6 std off product code: - 157001120 lot no: - dv6kd1 and one non-conformances was identified, however not related to the reported failure mode of the complaint.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 sz6 std off product code:- 157001120 lot no:- dv6kd1 quantity of manufactured:- 10 date of manufacturing:- may-2009 expiry date:- may-2019.Device history review a manufacturing record evaluation was performed for the finished device product description:- summit por taper sz6 std off product code:- 157001120 lot no:- dv6kd1 and one non-conformances was identified, however not related to the reported failure mode of the complaint.Added: h4.

• Brand Name: SUMMIT POR TAPER SZ6 STD 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23780458
• Report Number: 1818910-2025-21671
• Device Sequence Number: 10105608
• Product Code: LPH
• UDI-Device Identifier: 10603295059370
• UDI-Public: (01)10603295059370(17)190501(10)DV6KD1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 157001120
• Device Lot Number: DV6KD1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female