MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 PINNACLE DM LINER TRIAL 58_49; HIP INSTRUMENTS : ACETABULAR TRIAL

Catalog Number	221858049
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 event did not happen in surgery.Pdm trial is burnt from autoclave.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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 that 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.H11 additional narrative: added: d10 if information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.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 the event did not happen in surgery.Pdm trial is burnt from autoclave.Cup handle cracked.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did not found foreign substance, however signs of burnt were observed at the edge of the pinnacle dm liner trial 58_49 confirming the misuse allegation.This type of damage was consistent with the device coming in contact with a heated instrument or surface.Properly handling and attention to the approved use of the device diminishes the risk of failure.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinnacle dm liner trial 58_49 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to user, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE DM LINER TRIAL 58_49
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20091475
• Report Number: 1818910-2024-18291
• Device Sequence Number: 7688182
• Product Code: HWT
• UDI-Device Identifier: 10603295520580
• UDI-Public: (01)10603295520580(10)AZ343462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 221858049
• Device Lot Number: AZ343462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/08/2024; 10/09/2024; 10/17/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/09/2024; 10/14/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown