MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 47; HIP FEMORAL HEAD

Catalog Number 999890247

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

On (b)(6) 2017: attorney letter received indicating the preservation of the depuy device that is scheduled to be explanted on (b)(6) 2017.There is no reported adverse event at this time.Update (b)(6) 2017: patient was revised to address pain and metallosis.Added complainant information.(b)(6) 2017: litigation record received.Litigation also alleges discomfort and elevated metal ions.This complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4) 2017: attorney letter received indicating the preservation of the depuy device that is scheduled to be explanted on (b)(4) 2017.There is no reported adverse event at this time.Update (b)(4) 2017: patient was revised to address pain and metallosis.Added complainant information.(b)(4) 2017: litigation record received.Litigation also alleges discomfort and elevated metal ions.This complaint was updated on: (b)(4) 2017.Update (b)(4) 2017: ppd received.There is no new information.This complaint was updated on (b)(4) 2017.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received.After review of medical records, the patient was revised to address metallosis.Operative findings include moderate amount of metallosis debris with minimal trunnion wear.The stem was retained and asr xl components were explanted.Doi: (b)(6) 2008 - dor: (b)(6) 2017 (right hip).

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.H6 patient code: no code available (3191) used to capture the patient code surgical intervention and medical device removal.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 47
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7002207
• MDR Text Key: 91054294
• Report Number: 1818910-2017-28118
• 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: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 999890247
• Device Lot Number: 2578993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• 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: 73 YR