MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN DEPUY ASR ACETABULAR CUP; HIP ACETABULAR CUP

Catalog Number UNK-ASR

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104)

Event Date 07/17/2014

Event Type  Injury  

Event Description

Update rec'd (b)(6) 2014 - litigation papers received.Litigation alleges pain, tissue damage from metallosis, and cobalt and/or chromium poisoning.The doi was provided.The stem is being added to the complaint.There is no new additional information that would affect the investigation.The complaint was updated on: (b)(6) 2014.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this investigation closed.

Event Description

Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Medical records indicate patient was revised due to pain.Upon revision, metallosis debris and insignificant bone ingrowth on the acetabular cup were noted.

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 this investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.Depuy synthes has been informed that the catalog number and lot number is not available.

• Brand Name: UNKNOWN DEPUY ASR ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.-8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL 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: 4275078
• MDR Text Key: 5174354
• Report Number: 1818910-2014-32512
• Device Sequence Number: 1
• Product Code: KWA
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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?: Yes
• Date Manufacturer Received: 11/26/2014
• 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: 62 YR