MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936156
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Tissue Damage (2104); Joint Dislocation (2374); Not Applicable (3189)
Date of Event	03/22/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem 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 prosthetic 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.
Additional Manufacturer Narrative
Pc-(b)(4).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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MAR +4 10D 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7544842
• Report Number: 1818910-2018-60594
• Device Sequence Number: 11059703
• Product Code: LPH
• UDI-Device Identifier: 10603295014591
• UDI-Public: 10603295014591
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2014
• Device Catalogue Number: 121936156
• Device Lot Number: DK4JL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR