MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR FEM IMPLANT SZ 49; HIP METAL FEMORAL HEADS

Catalog Number 999890049

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

Patient Problems Pain (1994); Limb Fracture (4518)

Event Date 06/01/2008

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.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.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.

Event Description

Update ad (b)(6) 2023 litigation records received.Patient was revised due to fractured femoral neck of an asr resurfacing component at left hip.Indication of the procedure is to relieve pain and improve function.Doi: (b)(6) 2008.Dor: (b)(6) 2008 ( unk femoral head ).Affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.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: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: DEPUY ASR FEM IMPLANT SZ 49
• Type of Device: HIP METAL FEMORAL HEADS
• 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: 17661343
• MDR Text Key: 322390716
• Report Number: 1818910-2023-17948
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/31/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2012
• Device Catalogue Number: 999890049
• Device Lot Number: 2317052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male