MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 41; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890141

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.

Event Description

Revision due to pain.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4) superseded by mdd capa-(b)(4).Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore no dhr (device history record) review for this individual asr component will be carried out at this point in time.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Wwcapa (b)(4) superseded by mdd capa (b)(4) has been established regarding root cause and/or corrective actions.Further determinations and actions will be documented in the corrective and preventative action investigation as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.H10 additional narrative product complaint (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Adverse event report form recieved indicating that the patient was revised to address limited motion after hip joint replacement, soreness aggravated by walking, scar osteophyte proliferation around the acetabulum and bone absorption.

Manufacturer Narrative

Product complaint # (b)(4).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.Patient code: no code available ((b)(4)) used to capture the patient code device revision or replacement.Patient code: injury ((b)(4)) used to capture the patient code bone injury.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 41
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8431602
• MDR Text Key: 139166359
• Report Number: 1818910-2019-87653
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890141
• Device Lot Number: 2556720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR