MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Synovitis (2094); Insufficient Information (4580)

Event Date 12/13/2023

Event Type  Injury  

Event Description

Revision of ceramic inlay because of fracture.

Manufacturer Narrative

Product complaint (b)(4).B3: date of event is an unknown date.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).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).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, ¿revision of ceramic inlay because of fracture¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with a manufacturing investigation performed by supplier.Visual analysis of the returned sample revealed that the rim of the ea delta cer insert 36idx52od has fracture into one (1) large and twelve (12) small fragments.However, the ceramic liner cannot be completely reconstructed from the returned fragments.There are fragments missing which could potentially yield further information if they were available.Metal transfer patterns of erratic appearance were found all over the surface of the liner, most likely caused by chafing between metal parts and the broken fragments of ceramic, either after the primary fracture event or during the surgical procedures.Additionally, symmetrical metal transfer patterns around the whole circumference of the center and top section of the taper was not found.This indicates insufficient or misalignment fixation of the insert in the acetabular cup.Furthermore, intensive metal transfer can be located in the bottom section of the taper.This metal transfer indicates a misaligned position of the liner in the cup, too.However, it cannot be determined whether this metal transfer occurred prior to or after the primary fracture event.The fracture surfaces of the large fragment presents signs of secondary chip-offs since the fragments chafed against each other in the period between the primary fracture event and the delivery of the fragments for investigation.Due to the observed condition of the device and the missing fragments, the primary fracture surface and the fracture origin cannot be identified.Due to the chafing of the ceramic fragments, it is reasonable that noise would be presents.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the ceramic liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device [121881752 / 3954554] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The density of the liner was analyzed and found to comply with the material specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.The overall complaint was confirmed as the observed condition of the ea delta cer insert 36idx52od 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 acceptance certificate were reviewed.The quality documents show that the data obtained on the liner conformed to the specification valid at the time of production.1) quantity manufactured: (b)(4), 2) date of manufacture: 07-oct-2022, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: sep-2027, 5) ifu reference: 78002788.The density of the liner was analyzed and found to comply with the material specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.Device history review : a manufacturing record evaluation was performed for the finished device [121881752 / 3954554] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• 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: 18363751
• MDR Text Key: 330988420
• Report Number: 1818910-2023-25654
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881752
• Device Lot Number: 3954554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female