MAUDE Adverse Event Report: DEPUY INTL., LTD. - 8010379 UNKNOWN DEPUY ASR FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 11/14/2014

Event Type  Injury  

Event Description

Asr revision reported via sales rep, asr x,l unknown hip side.Patient was revised for suspected loosening of asr xl cup.The cup was not grossly loose but has fibrous ingrowth.Update rec'd (b)(6) 2014 - litigation papers received.Litigation papers allege pain, stiffness, discomfort, weakness and excessive metal ion levels.The doi was updated.The existing mdr decision has been reversed and the femoral head and adapter sleeve have been reported.The stem is being added to the complaint.The complaint was updated on: (b)(6) 2014.

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 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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.Udi: unavailable see section d for any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4421364
• MDR Text Key: 5421121
• Report Number: 1818910-2015-11168
• Device Sequence Number: 1
• Product Code: KWY
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/23/2014

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: Physician
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/15/2015
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR