MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-11-052
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
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 the surgeon was implanting the hole eliminator and rather than the hole eliminator stopping when all the way down, it went all the way through the cup.The surgeon was not happy.He decided the cup was well fixed and could be more problematic to remove the cup to retrieve the hole eliminator than to leave it the way it was.He decided to put the liner into the cup and move on.It was also indicated that there was a surgical delay of 3 minutes.
Additional 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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: PINNACLE 100 HA ACET CUP 52MM
• Common Device Name: 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12882543
• Report Number: 1818910-2021-26371
• Device Sequence Number: 4906811
• Product Code: LPH
• UDI-Device Identifier: 10603295009061
• UDI-Public: 10603295009061
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1217-11-052
• Device Catalogue Number: 121711052
• Device Lot Number: 9613285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOLE ELIMINATOR; PINNACLE 100 HA ACET CUP 52MM
• Patient Age: 53 YR
• Patient Sex: Male