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 Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Type  Injury  

Event Description

Litigation alleges damage to the tissue and structure of the hip, synovitis, mechanical complications, hyperactive synovium, bursal and joint scarring, chromium and cobalt toxicity, pain, and disfigurement.

Manufacturer 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.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd (b)(6) 2016 amended supplemental received stating patient has been revised.There is no new information that would change the exiting mdr decision.

• 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 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 3910718
• MDR Text Key: 4494539
• Report Number: 1818910-2014-22546
• Device Sequence Number: 1
• Product Code: KXA
• 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,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• 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?: No
• Date Manufacturer Received: 11/03/2016
• 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): Other