MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Inflammation (1932); Pain (1994); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Update ad 4 apr 2023 litigation records received.Patient suffered high levels of toxic metallic debris in her blood that emanated from the asr products that were implanted during her hip replacement surgery on (b)(6) 2009 and she has suffered pain, swelling, inflammation, and damage to the bones and tissue surrounding, delayed healing of the surgical incision from the revision surgery; she has been caused to suffer severe physical pain, keen mental anguish, and emotional distress; she has a diminished earning capacity and has been handicapped in her every day activities; she has incurred medical and hospital expenses that she otherwise would not have incurred and she will continue to incur these expenses in the future; and, she has residual and permanent disabilities and impairments, physical, mental and emotional.On (b)(6) 2022 , patient underwent a debridement procedure of the left hip as a result of delayed healing of the surgical incision with drainage from the revision surgery.Doi: (b)(6) 2009.Dor: (b)(6) 2022.Affected side: left hip.

Manufacturer Narrative

Product complaint #:(b)(4).The device catalog number is unknown; therefore, udi is unavailable.Investigation summary: 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.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16768480
• MDR Text Key: 313571725
• Report Number: 1818910-2023-08192
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female