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

Catalog Number 121882748

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem Fall (1848)

Event Date 07/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient was admitted as an emergency inpatient with a fracture of the ceramic inlay after a fall.Intraoperatively exchange of the broken ceramic inlay - "this is rather an inlay fracture that has existed for a long time, as the inlay was almost completely pulverized." doi: (b)(6) 2023.Doe: (b)(6) 2023.Affected side: unknown.

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).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.The pe code was updated from implant bearing wear - ceramic to implant fracture post-op ceramic.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary.Hcp is reporting to nca/bfarm: "condition after initial implantation of a cementless right hip tep on (b)(6) 2013; the patient was admitted as an emergency inpatient with a fracture of the ceramic inlay after a fall.Intraoperatively exchange of the broken ceramic inlay - this is rather an inlay fracture that has existed for a long time, as the inlay was almost completely pulverized." 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.Further details of the device's analysis were attached on "240311 final report kiv 23 08 11.Pdf".Visual analysis of the returned sample revealed that the delta cer insert 32id x 48od has fracture into five (5) large, seven (7) small and a number of very small fragments of ceramic.Based on the returned fragments, the ceramic was not able to be completely reconstructed.A secondary metal transfer of erratic appearance were found on the large fragments, most likely caused by chafing between metal parts and the broken fragments of the ceramic liner, either after the primary fracture of during the surgical procedures.Additionally, metal transfer patterns around the edge that suggest a symmetrical taper fit between the liner and the acetabular cup cannot be found.However, due to the high number of missing fragments, the expected metal transfer cannot be evaluated sufficiently.The fracture surfaces 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 secondary damage and the 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, two possible events may have occurred.The degree of destruction of the ceramic liner and the observed secondary edge chippings indicate a potential fracture some time before the patient's fall.This fracture could have been cause by a misaligned seating of the liner in the acetabular cup.Its is possible that only small fragments of the insert were chipped-off and a remaining large portion of the liner remained stable inside the cup.It is unclear why such a fracture was not noticed.However, it cannot be ruled out that the liner did not fractured in situ before the fall.If there was a pre-existent fracture, the patient's fall could then have a catastrophic fracture of the so-far stable insert remnant.Even if there is not sufficient evidence to clearly determine whether the insert was properly seated or not, it can be assumed that the referenced fall event would negatively influenced the performance 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 / 7773633] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The density of the insert was analyzed and fount o comply with the delivery specification for biolox delta components.The microstructure as obtained from the quality documents fulfil the requirements as 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 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: 1) quantity manufactured:(b)(4).2) date of manufacture: 9/1/2013.3) any anomalies or deviations identified in dhr: none 4) expiry date: 2018/08.5) ifu reference: 78002788.Device history batch: null.Device history review: a manufacturing record evaluation was performed for the finished device [121882748 / 7773633] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The density of the insert was analyzed and fount o comply with the delivery specification for biolox delta components.The microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production, too.There is no indication of any pre-existing material defect.

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: PINNACLE HIP SYSTEM : 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 46581-0988 ; 3035526892
• MDR Report Key: 17479697
• MDR Text Key: 320590787
• Report Number: 1818910-2023-16227
• 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,Followup
• Report Date: 08/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 7773633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 10/02/2023; 03/15/2024; 03/19/2024
• Supplement Dates FDA Received: 10/01/2023; 10/03/2023; 03/15/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: UNK HIP FEMORAL HEAD CERAMIC
• Patient Outcome(s): Required Intervention
• Patient Sex: Female