MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN LNR CONS NEUT +4 36IDX56OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-36-656
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
It was reported that patient had a right hip revision done somewhere in (b)(6) about 5 years ago.The surgeon put in a constrained liner because the patient was dislocating.The patient showed up to the er with a dislocated hip and surgeon said the patient had dislocated with a constrained liner from the x-ray and he wanted to do a new head/liner exchange.During the surgery, the surgeon removed the metal head and notice that there was metal debris, and the surgeon thought that this patient might have been dislocated for awhile because i guess this patient isn't very mobile.The surgeon removed the liner and implanted the same size constrained liner and chose to do a ceramic head of the same length.He was happy with the stability and leg lengths doi: 5 years ago; dor: (b)(6) 2020; affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.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: PIN LNR CONS NEUT +4 36IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10271155
• Report Number: 1818910-2020-15786
• Device Sequence Number: 3398998
• Product Code: KWZ
• UDI-Device Identifier: 10603295012122
• UDI-Public: 10603295012122
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1218-36-656
• Device Catalogue Number: 121836656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE M HEAD 36MM +8.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR