MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 36ID X 60ID; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881760

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

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

Breakage of ceramic insert when impacted into pinnacle gription 100 cup sz60.Small chipping of a 2cm part of the edge of the inlay.Only central impaction - no periphere force could be watched as a reason.The surgery was delayed due to the challenge of struggling for removal of the broken, but well impacted ceramic.Several fragments had been generated and needed quite some effort to be evacuated.The procedure was finally successfully completed by using an altrx poly- insert.Surgery was delayed 25 minutes due to the reported event.

Event Description

Additional information received: a.Was there any patient harm relevant to this event? if yes, please kindly provide details.There has been no specific harm for the patient, but or time had been significantly extended (appr.20min) due to the difficult removal of the fully impacted, broken ceramic insert! b.Did it break into two or more pieces? if no, please specify the alleged deficiency of the instruments.Were they bent, stripped, cross-threaded, etc.? one thin piece split from the edge of the liner, 1,5cm long.There was no obvious deficiency of the used straight impactor.Pictures will be attached.C.Did the event occur during primary or revision surgery? if revision surgery, what was the reason for revision? event occurred during primary surgery.D.Was there any allegation against the cup? if yes, please specify.No.

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, ¿breakage of ceramic insert when impacted into pinnacle gription 100 cup sz60.Small chipping of a 2cm part of the edge of the inlay.Only central impaction - no periphere force could be watched as a reason (sales rep witnessed this accident live and personally)! the surgery was delayed due to the challenge of struggling for removal of the broken, but well impacted ceramic.Several fragments had been generated and needed quite some effort to be ¿evacuated¿ :-( the procedure was finally successfully completed by using an altrx poly- insert.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachments "(b)(4)_c3d93e02-2aa5-411f-8d86-a36f29734058" "(b)(4)_b9d60c80-7793-41b0-b2bf-9402576b84f7" and "(b)(4)_090fcc18-adde-4dc1-a434-5fe2f78e18e6" review of the photographic evidence revealed that the rim of the delta cer insert 36id x 60id has fracture into multiple pieces, fragments can be observed on the provided evidence.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences during the surgical process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [121881760 / 9239502] number, and no non-conformances / manufacturing irregularities 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 ceramic liner 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
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> protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the ceramic 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
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> a manufacturing record evaluation was performed for the finished device [121881760 / 9239502] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: DELTA CER INSERT 36ID X 60ID
• 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 ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18967580
• MDR Text Key: 338470713
• Report Number: 1818910-2024-06440
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 03/25/2024

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 121881760
• Device Lot Number: 9239502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/05/2024; 05/02/2024
• Supplement Dates FDA Received: 04/09/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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
• Patient Age: 72 YR
• Patient Sex: Male