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

Catalog Number 121881752

Device Problems Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

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: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device product code:121881752, lot number: 3849355 and no non-conformances / manufacturing irregularities were identified.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "during the procedure of total hip arthroplasty, when opening the component "ceramic insert", it was observed that the product came broken.Immediate action: another component was opened for completion of the procedure".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 "240319 final report kiv 23 07 02_rp.Pdf".Visual analysis of the delta cer insert 36id x 60id revealed that the liner was returned fractured inside the sterile packaging and outer carboard box.It is worth mentioning that the tyvek seal was found tear open and part of the inner packaging and the patients labels were not returned.The rim of the liner was found chipped, fragment was not returned for evaluation.Next to the fracture surface metal transfer can be found which indicates small areas of intensive contact between the ceramic liner and the acetabular cup, most likely due a tilted position of the liner during the impaction.Additionally, metal transfer patterns around the circumference of the top and center section of the taper that suggest a symmetrical taper fit between the liner and the acetabular cup cannot be found.Based on the visual examination, the reported allegation of the devices being broken upon receipt cannot be confirmed since the failure analysis performed by the supplier leads to the conclusion that the metal transfer and chip-off, most likely occurred during attempts to impact or release the insert from the acetabular cup.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 misalignment during the process of positioning the liner in the acetabular cup.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 [121881752 / 3849355] number, and no non-conformances / manufacturing irregularities related to the malfunction 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 ea delta cer insert 36idx52od would contribute to a 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 (b)(4).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.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 [121881752 / 3849355] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17061360
• MDR Text Key: 316688587
• Report Number: 1818910-2023-11606
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2023

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 Catalogue Number: 121881752
• Device Lot Number: 3849355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 07/04/2023; 07/18/2023; 09/12/2023; 03/25/2024
• Supplement Dates FDA Received: 07/05/2023; 07/18/2023; 09/13/2023; 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• 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