MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical records received.After medical records review patient was revised due to recent experience in increased left hip pain and elevated cobalt-chromium levels with positive fluid collection as seen on mars mri.Operative note reported.The hip was dislocated and the unipolar large femoral head was removed in its entirety, demonstrating a significant wear along the trunnion with a black cobalt chromium material.Doi: (b)(6) 2007; dor: (b)(6) 2024; left 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.Product description: summit por taper sz7 hi off.Product code: 157011135.Lot number: a2wdl1000.Manufacturing date: 14-aug-2006.Expiry date: na.Quantity manufactured: (b)(4).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 sz7 hi off.Product code: 157011135.Lot number: a2wdl1000.Manufacturing date: 14-aug-2006.Expiry date: na.Quantity manufactured: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device lot-a2wdl1000, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SUMMIT POR TAPER SZ7 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19920339
• Report Number: 1818910-2024-16903
• Device Sequence Number: 18042946
• Product Code: LPH
• UDI-Device Identifier: 10603295060086
• UDI-Public: (01)10603295060086(17)110814(10)A2WDL1000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: 08/14/2011
• Device Catalogue Number: 157011135
• Device Lot Number: A2WDL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2006
• 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: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male