MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882748

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that there was a device interaction between the liner and cup.

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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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).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.

Event Description

Additional information was received.And stated, that no patient consequence.Another device was used to complete the procedure.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "the insert was too far in one side and not far enough on the other.Impossible to place it properly.Use of another device to complete the procedure: removal of the cup previously placed (product code 121722048 - lot 4021194) with insert and change of the cup and the insert.Surgical delay".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that delta cer insert 32id x 48od was returned fixated in a slightly tilted position inside the acetabular cup.Additionally, organic material was observed between the ceramic liner and the acetabular cup.However, no defects or signs of a device non conformance were observed.A dimensional inspection was performed for the delta cer insert 32id x 48od and met specification.Additionally, the dimensional protocols of the liner were reviewed by the supplier.The measurement results show that the dimensions were within the specified tolerance.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the involved implants may have been caused by a misalignment during the process of positioning the ceramic liner.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during the surgical process.A manufacturing record evaluation was performed for the finished device [4086634 / 121882748] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the delta cer insert 32id x 48od would contribute to the complained device issue.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: protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert conformed to the specification valid at the time of production.Additionally, the supplier reviewed the dimensional protocols of the involved device.The measurement results show that the dimensions were within the specified tolerance.Device history review: a manufacturing record evaluation was performed for the finished device [4086634 / 121882748] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18275730
• MDR Text Key: 330332981
• Report Number: 1818910-2023-24744
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P070026
• 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,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 4086634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/11/2024; 01/11/2024; 04/10/2024
• Supplement Dates FDA Received: 01/16/2024; 01/17/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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: PINNACLE SECTOR II CUP 48MM