MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-056
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2020
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 according to the surgeon, patient experienced pinnacle liner dissociation, as evidenced on x-ray.This finding was confirmed intra-op.Multiple ard tabs were broken off of the liner.The surgeon elected to keep the pinnacle shell, replacing the liner and femoral head.Doi: (b)(6) 2003; dor: (b)(6) 2020; right side.
Event or Problem Description
Additional information received stated that the patient received a primary right tha to treat osteoarthritis of the hip.The surgeon noted that the natural interior-anterior acetabular wall was deficient, requiring cup placement in 40-45 degrees abduction and 25-30 degrees anteversion.The procedure was completed without complications.The patient received a pinnacle cup with apex hole eliminator, marathon polyethylene liner, articuleze femoral head, and summit stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The provided x-ray images were able to confirm the reported disassociation event.The root cause could not be determined.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.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: PINNACLE 100 ACET CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10252004
• Report Number: 1818910-2020-15412
• Device Sequence Number: 19005129
• Product Code: LPH
• UDI-Device Identifier: 10603295008576
• UDI-Public: 10603295008576
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2020

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: 1217-01-056
• Device Catalogue Number: 121701056
• Device Lot Number: XA8G21015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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 ELIMINATOR; ARTICUL/EZE BALL 28 +5 BR; PINN MAR NEUT 28IDX56OD; SUMMIT POR TAPER SZ4 STD OFF; APEX HOLE ELIMINATOR; ARTICUL/EZE BALL 28 +5 BR; PINN MAR NEUT 28IDX56OD; SUMMIT POR TAPER SZ4 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR