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

Catalog Number 121882748

Device Problem Fracture (1260)

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

Event Date 02/04/2024

Event Type  malfunction  

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 Description

Liner breakage.It was reported that during the surgery, after blows, the liner was broken, all the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: liner breakage.It was reported that during the surgery, after blows, the liner was broken, all the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence revealed that the delta cer insert 32id x 48od has fractured into multiple pieces, fragments of different sizes covered with organic material can be seen in the photo.With the information available is not possible to determine a potential cause at this moment.The failure mode of the device is multifactorial and all possible influences must be taken into account during the surgical process.A manufacturing record evaluation was performed for the finished device [121882748 / 4255472] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect 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.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect device history review: a manufacturing record evaluation was performed for the finished device [121882748 / 4255472] 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18662059
• MDR Text Key: 334797375
• Report Number: 1818910-2024-02625
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 4255472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1