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

Model Number	1217-20-056
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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
The primary surgery was performed on (b)(6) 2011 via tha of the patient¿s right hip joint.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the cup, the liner, the head, and the stem with the sleeve due to dislocation caused by fall down.It was confirmed that the cup was implanted at superior side of the acetabulum at the primary surgery and the lateral opening angle was about 60 degrees.The surgery was completed without a surgical delay.

• Brand Name: PINNACLE MULTIHOLE II 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: 9727090
• Report Number: 1818910-2020-05245
• Device Sequence Number: 2474965
• Product Code: KWA
• UDI-Device Identifier: 10603295009641
• UDI-Public: 10603295009641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 1217-20-056
• Device Catalogue Number: 121720056
• Device Lot Number: E76NH1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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