MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 ADAPTER SLEEVE 11/13 +3; HIP OTHER IMPLANT

Catalog Number 999890343

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised due to pain.

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.Wwcapa (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 this case closed to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation documents received.Litigation alleges that patient underwent a revision to address pain, cup loosening, limited mobility, shedding of metal debris and elevated metal ions.

• Brand Name: ADAPTER SLEEVE 11/13 +3
• Type of Device: HIP OTHER IMPLANT
• 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: 5209214
• MDR Text Key: 30681213
• Report Number: 1818910-2015-34611
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK965156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2011
• Device Catalogue Number: 999890343
• Device Lot Number: 2177796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• 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: 53 YR
• Patient Weight: 132