MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722056

Device Problem Metal Shedding Debris (1804)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Date 03/22/2011

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.

Event Description

Pinnacle ppf and medical records received.Ppf alleges dislocation and infection.After review of medical records for the mdr reportability, the patient was revised to address right hip deep prosthethic infection and cup revision with sciatic neurolysis.Revision notes reported of fair degree metallosis and also reported that a scant amount of fluid was sent out of culture which appeared clear, without evidence of infection.It was also reported that several cultures of hip did not reveal any positive growth and there was a fair degree of metallosis again with cloudy-appearing fluid both superficial and deep to his fascia , particularly in the acetabular component.The acetabular component had some long-term wear secondary to the metal head articulating with it long term when he still had the misplaced metal liner.Doi: (b)(6) 2010; dor: (b)(6) 2011; right hip.See (b)(4) for the first revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7544843
• MDR Text Key: 109267933
• Report Number: 1818910-2018-60590
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Catalogue Number: 121722056
• Device Lot Number: Z63BY1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2018
• Date Device Manufactured: 11/28/2005
• 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: 55 YR