MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-052

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Lack of coupling between apex and threaded hole of the shell.Apex hole has a smaller diameter than the threaded hole on the shell.After screwing, it sinks into the acetabulum.Affected side: right, primary surgery.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 SECTOR II CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10670101
• MDR Text Key: 211021810
• Report Number: 1818910-2020-22124
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: 9380861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP