MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TAPER SLEEVE ADAPTER 12/14 +2; HIP OTHER IMPLANT

Catalog Number 999800102

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/03/2013

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

New etq record created in roder to update etq (legacy system) complaint number(b)(4).Reason for original complaint - asr revision due to take place on (b)(6) 2013.Right asr xl reason(s) for revision: pain.Update - added revision date taken from claimsuite dated (b)(6) 2013.Update dec 1, 2017: email notification from kennedys received.Updated complainant address.This complaint was updated on: dec 4, 2017.

Manufacturer Narrative

Additional narrative: new etq record created in roder to update etq (legacy system) complaint number dint(b)(4).Reason for orignal complaint - asr revision due to take place on (b)(6)2013 right asr xl reason(s) for revision: pain update - added revision date taken from claimsuite dated (b)(6)2013 update dec 1, 2017: email notification from kennedys received.Updated complainant address.This complaint was updated on: dec 4, 2017.The reported event has been evaluated and will be monitored.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.

• Brand Name: TAPER SLEEVE ADAPTER 12/14 +2
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL 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: 7139484
• MDR Text Key: 95534344
• Report Number: 1818910-2017-29754
• 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: consumer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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: Health Professional
• Device Catalogue Number: 999800102
• Device Lot Number: 2540748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention