MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN LNR CONS NEUT +4 36IDX58OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Catalog Number	121836658
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/03/2019
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 the patient dislocated her constrained liner.During the revision, the liner was removed and discovered to have a crack on the outer elevated edge of the poly.The locking ring was observed to be still in place on the exterior of the polyand the 36 ts femoral head was still attached to the femoral stem.Constrained liner was destroyed during the removal process by the surgeon.The surgeon chose to remove the femoral stem, which was well-fixed, for a modular revision stem in order to increase femoral anteversion.Revised to a tripolar.No history of falls or additional explanation for the dislocation.Doi: (b)(6) 2019; dor: (b)(6) 2019, left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: PIN LNR CONS NEUT +4 36IDX58OD
• 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: 8724075
• Report Number: 1818910-2019-96510
• Device Sequence Number: 19338336
• Product Code: KWZ
• UDI-Device Identifier: 10603295012139
• UDI-Public: 10603295012139
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K043058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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 Catalogue Number: 121836658
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: 78 YR