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

Catalog Number 121881754

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Patient of (b)(4) (= 2nd revision) was revised before.This complaint ((b)(4)) covers the first revision: revision of inlay and hip head because of noises of coc pairing right side.During revision the ceramic inlay fractured.

Manufacturer Narrative

Product complaint # (b)(4).Additional event information: on (b)(6) 2014 right cement-free hip arthroplasty occurred.The patient developed pronounced noise of the ceramic-ceramic sliding combination used.Revision took place (b)(6) 2018 ((b)(4)) during the (b)(6) 2018 revision a rupture of the ceramic inlay occurred.The patient dislocated twice in 2018 with a closed reduction in each case.There was no surgical delay.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 that 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 was received: a surgical delay was not reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, ¿patient of (b)(4)(= 2nd revision) was revised before.This complaint (b)(4) covers the first revision: revision of inlay and hip head because of noises of coc pairing right side.During revision the ceramic inlay fractured.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachments "02819-24 präop2018b" "implantate ph 2018 g" "implant at (b)(6)" "02819-24 präop2018a" "02819-24 postop2018b" and "02819-24 postop2018a".Review of the returned radiological images revelated that ea delta cer insert 36idx54od presents no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.A manufacturing record evaluation was performed for the finished device [121881754 / 3580351] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.The overall complaint was not confirmed as the radiological images provided contained insufficient evidence of the reported event.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: 19-feb-2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: jan-2018.5) ifu reference: 78002788.Device history review: a manufacturing record evaluation was performed for the finished device [121881754 / 3580351] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.1) quantity manufactured: (b)(4).2) date of manufacture: 19-feb-2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: jan-2018.5) ifu reference: 78002788.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18710838
• MDR Text Key: 335467089
• Report Number: 1818910-2024-03343
• 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: 02/15/2024

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 Expiration Date: 01/31/2018
• Device Catalogue Number: 121881754
• Device Lot Number: 3580351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 05/06/2024
• Supplement Dates FDA Received: 02/16/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; CORAIL2 NON COL HO SIZE 14; DELTA CER HEAD 12/14 36MM +5; PINNACLE 100 ACET CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male