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

Catalog Number 121881752

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/06/2023

Event Type  Injury  

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

Revision of ceramic inlay because of pain and fracture.Ceramic inlay chipped post-op.The implant is available in the clinic, but the chip cannot be washed because it is too small for washing screens.Doi: (b)(6) 2023.Doe: (b)(6) 2023.

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.Corrected h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "revision of ceramic inlay because of pain and fracture.Ceramic inlay chipped post-op.The implant is available in the clinic, but the chip cannot be washed because it is too small for washing screens".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 revealed that the rim of the ea delta cer insert 36idx52od has fractured into one (1) large, four (4) small and thirteen (13) very small fragments.However, the ceramic liner was not able to be completely reconstructed, there are fragments missing which could potentially yield further information if they were available.Metal transfer of erratic appearance can be found on the outer and inner surface of the large fragment, most likely caused by chafing between metal parts and the broken fragments of ceramic liner, either after the primary fracture of during the surgical procedures.Additionally, metal transfer patterns around the circumference of the taper that suggest a symmetrical taper fit between the liner and the acetabular cup cannot be found.The rim of the insert was found chipped over 270° of the circumference.Next to the chip-offs, metal transfer was observed which indicates a small area of intensive contact between the ceramic liner and the metal cup, mot likely due to a misaligned position.The broken fragments present 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 returned liner and due to missing fragments, the primary fracture surface and the fracture origin cannot be identified.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established.However in support of the evaluation performed, the observed damage of the liner may have been caused by a insufficient or misaligned fixation of the liner in the acetabular cup leading to a misaligned position of the liner causing locally increased mechanical stress.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 / 4179197] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The density of the liner was analyzed and found to comply with the delivery 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 : the ceramic insert belongs to the shop order 7011804174.Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the liner confirmed to the specification valid at the time of production.1) quantity manufactured: (b)(4).2) date of manufacture: 6/8/2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: 2028/ 05, 5) ifu reference: ifu-78002788.The density of the liner was analyzed and found to comply with the delivery 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 / 4179197] 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 ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18143500
• MDR Text Key: 328200073
• Report Number: 1818910-2023-23337
• 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
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: 4179197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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
• Patient Outcome(s): Required Intervention