MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY ACETABULAR LINER; HIP ACETABULAR INSERT/LINER

Catalog Number UNK-HIP

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 06/03/2014

Event Type  Injury  

Event Description

Medical records received from broadspire.Patient went through another revision on (b)(6) 2014 for repeated dislocations.After reading the revision operative note the cup and screw were also revised for instability.

Manufacturer Narrative

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

Manufacturer Narrative

Medical records received from (b)(6).Patient went through another revision on (b)(6) 2014 for repeated dislocations.After reading the revision operative note the cup and screw were also revised for instability.(b)(4).The devices associated with this report were not returned.Review of the device history records and/or a complaint database search was not possible as the product and lot codes required were not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.An implant summary record, and not medical records, was provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN DEPUY ACETABULAR LINER
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3968397
• MDR Text Key: 4628617
• Report Number: 1818910-2014-24585
• 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: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2014

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-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 07/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR