MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR HA ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712054
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon was putting the hole eliminator into the cup, and the hole eliminator went completely through the cup.The surgeon decided to leave it behind the cup, rather than removing the well-fixed cup.There was not a delay to the case.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, a2, a3, a4 and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that it was reported that the surgeon was putting the hole eliminator into the cup, and the hole eliminator went completely through the cup.The surgeon decided to leave it behind the cup, rather than removing the well-fixed cup.There was not a delay to the case.Surgeon concerned about whether or not there are more lot numbers in circulation that have this issue.X-ray from intra op is available if needed.Surgical delay unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "22_sep_2023_14_23_22_28217".The depuy synthes team forwarded the photo evidence to depuy cork which conducted visual inspection of the received evidence.Based on the current manufacturing investigation which has been completed, the following was concluded and result that the complaint is non-verifiable.The product was not returned, and there is no evidence to support the allegation made in the complaint.Visual analysis of the photo revealed that there was no damage or defects with the pinn sector ha acet cup 54mm.There is not enough evidence in the photo to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the pinn sector ha acet cup 54mm was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot dhr review was performed according to "lot 4145523 fg dhr for pi-16951503569261833 (b)(4)" attached on notes & attachments.1) quantity manufactured: (b)(4) parts were manufactured to specification.2) date of manufacture: 05/03/2023.3) any anomalies or deviations identified in dhr: 2 non-conformances associated with this lot.There is no correlation between these nonconformance and the failure mode of the complaint.4) expiry date: 04/30/2033.5) ifu reference: ifu-0902-00-701.Device history review (b)(4) quantity manufactured: (b)(4) parts were manufactured to specification.2) date of manufacture: 05/03/2023.3) any anomalies or deviations identified in dhr: 2 non-conformances associated with this lot.There is no correlation between these nonconformance and the failure mode of the complaint.4) expiry date: 04/30/2033.5) ifu reference: ifu-0902-00-701.

• Brand Name: PINN SECTOR HA ACET CUP 54MM
• 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17798976
• Report Number: 1818910-2023-19319
• Device Sequence Number: 7249348
• Product Code: LPH
• UDI-Device Identifier: 10603295009177
• UDI-Public: 10603295009177
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/22/2023

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 Catalogue Number: 121712054
• Device Lot Number: 4145523
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 11/28/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/02/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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: UNK HIP ACETABULAR HOLE ELIMINATOR.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 113 KG