MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-156
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	01/21/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.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 medical records received.After review of medical records the patient was revised due to post left total hip arthroplasty with acute displacement of polyethylene liner probably secondary to an episode of instability.There was some anterior wear on the 10 degrees hip which could have come from perhaps a subluxation or perhaps neck impingement.There was some minimal wear on the head.The liner and head were removed.Doi: (b)(6) 2007- dor: (b)(6) 2010 (left hip, first revision).
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error since mrn 1818910-2020-20079 was found to be a duplicate report of mrn 1818910-2010-00577.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: PINN MAR +4 10D 32IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10535820
• Report Number: 1818910-2020-20079
• Device Sequence Number: 14153864
• Product Code: JDI
• UDI-Device Identifier: 10603295014072
• UDI-Public: 10603295014072
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 1219-32-156
• Device Catalogue Number: 121932156
• Device Lot Number: AN3D31000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +9 BL; ARTICUL/EZE BALL 32 +9 BL; PINN MAR +4 10D 32IDX56OD; PINNACLE SECTOR II CUP 56MM; PRODIGY SM STAT LNG LT 13.5MM; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +9 BL; ARTICUL/EZE BALL 32 +9 BL; PINN MAR +4 10D 32IDX56OD; PINNACLE SECTOR II CUP 56MM; PRODIGY SM STAT LNG LT 13.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR