MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-054

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that the hole eliminator seemed to not come to a stop.Took an intra-op c-arm shot and could not see that it was protruding past the cup.Surgeon backed it out a bit and let in the cup before impacting the liner.Doi: unknown - dor: (b)(6) 2021 (unknown side).

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for this product/lot combination and no non-conformances / manufacturing irregularities were identified.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 was performed for the finished device 121732054, lot 9871421, and no non-conformances / manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device 121732054, lot 9871421, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12869819
• MDR Text Key: 281214106
• Report Number: 1818910-2021-26299
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010319
• UDI-Public: 10603295010319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-32-054
• Device Catalogue Number: 121732054
• Device Lot Number: 9871421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINN SECTOR W/GRIPTION 54MM
• Patient Age: 76 YR
• Patient Sex: Female