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

Catalog Number 121882748

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Joint Dislocation (2374)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Patient has been complaining of a "clunking" hip replacement after 2 years post-op.There has already been a revision change of head to the femoral stem to counteract the issue, but she still appears to be able to manually dislocate the hip with force.She has come back today for revision surgery again, this time to remove the cup and liner and replace with new components.Upon open the hip joint there were fragments of ceramic in the wound, this appeared to be from the ceramic liner as the head looks in pristine condition.Once cup was removed it appears there is a section of the ceramic liner that has fractured off, this is in line with the fragments found in the wound.The surgeon states that it is very hard to manually reproduce the dislocation the patient is experiencing.The head and liner both show signs of metal wear against components in keeping with the narrative of being able to dislocate at will.A new head, liner and cup were replaced.

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.

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 received.States, that the affected side was the left hip.

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.H10 additional narrative: added: d9 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, ¿patient has been complaining of a "clunking" hip replacement after 2 years post-op.There has already been a revision change of head to the femoral stem to counteract the issue, but she still appears to be able to manually dislocate the hip with force.She has come back today for revision surgery again, this time to remove the cup and liner and replace with new components.Upon open the hip joint there were fragments of ceramic in the wound, this appeared to be from the ceramic liner as the head looks in pristine condition.Once cup was removed it appears there is a section of the ceramic liner that has fractured off, this is in line with the fragments found in the wound.The surgeon states that it is very hard to manually reproduce the dislocation the patient is experiencing, but the patient uses this as a "party trick" to show the clunking to people.The head and liner both show signs of metal wear against components in keeping with the narrative of being able to dislocate at will.A new head, liner and cup were replaced as expected and i will follow-up in coming months to see if the same problem persists after this surgery¿.The product and photos (mg_0824.Jpg) were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The depuy synthes team conducted a visual inspection of the returned device along with a manufacturing investigation performed by supplier.Further details of the device's analysis were attached on "(b)(6) final report kiv 24 01 27_rp.Pdf".Visual analysis of the returned sample revealed that delta cer insert 32id x 48od was fixated in the acetabular cup.Additionally, the rim of the liner was fractured, fragments were not returned for evaluation and no evidence of the fragments being embedded to patient was provided.The ceramic liner cannot be completely reconstructed.There are fragments missing which could potentially yield further information if they were available.Metal transfer patterns of erratic appearance were found on the rim, on the inner surface and all over the fracture surface, 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 observed since the liner was returned fixated in the metal cup.Therefore, the primary metal transfer that suggest a symmetrical taper fit between the ceramic liner and acetabular cup cannot be evaluated.An intensive metal transfer can be found on the rim, indicating impingement between the stem and the ceramic liner.Additionally, partially smeared metal transfer was observed on the inner section of the liner and the polished surface of the returned femoral head.These metal transfer patterns could have been caused by small metal particles getting into the bearing; such small particles could have been created by impingement between the metal stem and the ceramic liner as previously mentioned.Signs of increased wear were also found on the inner surface of the liner.However, it cannot be determined whether these areas were generated by microseparation / edge loading prior to the fracture or caused by ceramic fragments and third-body wear after the primary fracture event.Based on the observed condition for the device, it is not unreasonable that noise would be present due to the chafing of the broken ceramic fragments and metal particles getting into the bearing between the liner and head.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.However in support of the evaluation performed, the reported edge-loading and recurring subluxations can lead to an increased mechanical stress, causing a fracture of the rim.Furthermore, base on the available information, the fact that the patient used a forced dislocation as a "party trick" may also have been and influencing factor for the fracture of the liner.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 [121882748 / 9656514] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing 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 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.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing material defect.Device history review: a manufacturing record evaluation was performed for the finished device [121882748 / 9656514] number, and no non-conformances / manufacturing irregularities 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 ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18274619
• MDR Text Key: 329836721
• Report Number: 1818910-2023-24689
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 9656514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 12/22/2023; 05/07/2024
• Supplement Dates FDA Received: 12/18/2023; 12/28/2023; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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: DLT TS CER HD 12/14 32MM +9; PINN SECTOR W/GRIPTION 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female