MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881754

Device Problem Fracture (1260)

Patient Problems Muscular Rigidity (1968); Pain (1994); Ambulation Difficulties (2544); Unspecified Musculoskeletal problem (4535)

Event Date 04/05/2023

Event Type  Injury  

Event Description

Operating surgeon shared a complaint that patient came back with broken liner and or head as per the current x-ray, patient is having pain also and requires revision surgery.

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.

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: b5, d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, d6a.

Event Description

Affected side 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: 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 indicated that a revision procedure was completed.

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: the device associated with this report was not returned to depuy synthes for evaluation.Visual examination of the device and review of the x-rays evidence confirm, the reported allegation.The rim of the ceramic liner was found fractured.Fragments have been chafing against each other causing a secondary chip-offs on the fractured surfaces.The broken fragments were not returned for evaluation.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 insert confirmed, to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfill 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: [121881754, 9768133] number.And no non-conformances / manufacturing irregularities were identified, during manufacturing.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16795236
• MDR Text Key: 313820660
• Report Number: 1818910-2023-08498
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/24/2023

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: 121881754
• Device Lot Number: 9768133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/02/2023; 05/26/2023; 06/07/2023; 08/25/2023
• Supplement Dates FDA Received: 05/04/2023; 06/01/2023; 06/07/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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: CANCELLOUS BONE SCREW 6.5X25MM; CORAIL2 STD SIZE 11; DELTA CER HEAD 12/14 36MM +5; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male