MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-050

Device Problem Difficult to Insert (1316)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/21/2020

Event Type  malfunction  

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 Description

Intraoperatively a hole eliminator slipped through the cup´s hole.It slipped through the socket and behind the cup and did not stop like it should.It was left in the space behind the cup.No adverse patient harm reported.Surgery completed successfully.No surgery delay: 10min.

Manufacturer Narrative

Product complaint # (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.Device history lot dhr has been reviewed and no deviations or anomalies were found.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

Manufacturer Narrative

Product complaint # (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.Device history lot: a manufacturing record evaluation were performed for the finished device 12170105, lot number 9553663, it was manufactured on 01-jul-2020.10 pcs parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

• Brand Name: PINNACLE 100 ACET CUP 50MM
• 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: 10627521
• MDR Text Key: 209809113
• Report Number: 1818910-2020-21580
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: 10603295008545
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2020

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: 1217-01-050
• Device Catalogue Number: 121701050
• Device Lot Number: 9553663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 12/17/2020; 01/12/2021
• Supplement Dates FDA Received: 12/16/2020; 12/17/2020; 01/13/2021
• 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