MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Catalog Number 124603000

Device Problem Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that the hole eliminator went straight through the cup.Surgeon said it didn¿t even feel the threads come together.Couldn¿t get the hole eliminator out of the patient without removing the cup.Decided to leave the hole eliminator in the patient.Surgery was delayed 3 minutes due to the reported event.Was procedure successfully completed? yes.Were fragments generated? no.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "hole eliminator went straight through the cup.Surgeon said it didn¿t even feel the threads come together.Couldn¿t get the hole eliminator out of the patient without removing the cup.Decided to leave the hole eliminator in the patient.Cup was consignment, hole eliminator was loan".The product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence revealed the patients labels of the involved implants, only the product code and lot number of the apex hole elim positive stop were observed.No other observation pertaining to the nature of the reported event could be identified.However, based on the finding of the manufacturing record evaluation (mre) performed on the involved acetabular cup, the reported event can be confirmed.The failure mode cannot be attributed to a non-conformance with the apex hole elim positive stop.A manufacturing record evaluation was performed for the finished device [124603000 / d22122594] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed based on the available information and findings of the mre performed on the involved implants.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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: a manufacturing record evaluation was performed for the finished device [124603000 / d22122594] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

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.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18578999
• MDR Text Key: 333724006
• Report Number: 1818910-2024-01726
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 124603000
• Device Lot Number: D22122594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 04/12/2024
• Supplement Dates FDA Received: 01/31/2024; 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL AMT COLLAR SIZE 12; PINNACLE SECTOR II CUP 50MM