MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE 100 ACET CUP 52MM; HIP ACETABULAR CUP

Catalog Number 121701052

Device Problems Disassembly (1168); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 02/08/2017

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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of pinnacle inlay as inlay disassociated from cup.Surgeon wrote: ¿patient reports a cracking noise while walking and after this a metallic rubbing and squeaking and pain.¿.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the reported devices confirms the reported disassociation.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.Medical records were reviewed.The investigation can draw no conclusion with the information provided.Product problem has not been identified.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.

• Brand Name: PINNACLE 100 ACET CUP 52MM
• Type of Device: HIP ACETABULAR CUP
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6379275
• MDR Text Key: 69093082
• Report Number: 1818910-2017-13991
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121701052
• Device Lot Number: 316533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2012
• 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: 45 YR
• Patient Weight: 95