MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINNACLE DM LINER 60_51; TOTAL HIP JOINT REPLACEMENT PROSTHESIS

Catalog Number	121860051
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had mdm implants in situ with active infection requiring a washout and replacement of head and liners.Implants were sent the morning of case, which started at 8:00.At 8:07 they couldn't be located.At this stage the surgeons were scrubbed for the case and the patient was anaesthetized.The surgeons agreed to slow down the surgery to give the courier more time to arrive, meaning that the patient had a longer anesthetic time than required.Was procedure successfully completed? --> yes was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 30+ minutes.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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: b5, d6a, d4 (lot, expiration date, udi), h4 corrected: d1, d4 (catalog) 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
Additional information was received: 1.Can you please confirm if the mdm implants are ours ! depuy? or stryker? depuy.2.The head and liner was not explanted nor re-implanted.3.Or implanted with new ones delivered by the driver? implanted with new ones.4.The patient was under anaesthecia for 3 hours.5.There was a 1 hour surgical delay.6.Has the patient follows normal clinical post op course? yes.7.No reports for further infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Product description:- pinnacle dm liner 60_51, product code:- 121860051, lot no:- 9864096, quantity of manufactured:- (b)(4).Date of manufacturing:- 07-sep-2021, expiry date:- 31-aug-2031.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 : product description:- pinnacle dm liner 60_51, product code:- 121860051, lot no:- 9864096, quantity of manufactured:-(b)(4).Date of manufacturing:- 07-sep-2021, expiry date:- 31-aug-2031.Device history review : a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.
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).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE DM LINER 60_51
• Common Device Name: TOTAL HIP JOINT REPLACEMENT PROSTHESIS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19383588
• Report Number: 1818910-2024-11427
• Device Sequence Number: 4036180
• Product Code: LPH
• UDI-Device Identifier: 10603295520313
• UDI-Public: (01)10603295520313(17)310831(10)9864096
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121860051
• Device Lot Number: 9864096
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 05/27/2024; 05/29/2024; 06/28/2024; 07/16/2024; 07/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/28/2024; 06/04/2024; 07/01/2024; 07/22/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2021
• 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: APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 28 +5 BR; ARTICUL/EZE BALL 28 +5 BR; BI MENTUM PFR PE LINER 5128; BI MENTUM PFR PE LINER 5128; UNKNOWN BI-MENTUM HIP ACETABULAR LINER; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown