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

Catalog Number 121881754

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/01/2018

Event Type  Injury  

Event Description

The patient dislocated twice in 2018 with a closed reduction in each case.There were no specific 2018 dates provided for this dislocation information and it can not be assumed that the event happened prior to the 2018 revision captured.

Manufacturer Narrative

(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

The dislocations occurred on (b)(6) 2018.A closed dislocation was performed in each case.No operations were performed.There have also been no complaints.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, the patient dislocated twice in 2018 with a closed reduction in each case.There were no specific 2018 dates provided for this dislocation information and it can not be assumed that the event happened prior to the 2018 revision captured.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The x-ray investigation revealed that ea delta cer insert 36idx54od had no dislocated from the cup.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the ea delta cer insert 36idx54od would not contribute to the complained device issue.Based on the investigation findings and 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 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 : product description: ea delta cer insert 36idx54od product code: 121881754 lot number: 3580351 1) quantity manufactured: (b)(4).2) date of manufacture: 19-feb-2013.3) any anomalies or deviations identified in dhr: there were no non-conformances associated whit this lot.4) expiry date: jan-2015) ifu reference: 78002788 option cup.

• 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18737403
• MDR Text Key: 335704819
• Report Number: 1818910-2024-03708
• 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
• Report Date: 02/20/2024

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?: No
• 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: 02/20/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 02/22/2024; 04/18/2024
• Supplement Dates FDA Received: 02/22/2024; 02/29/2024; 04/20/2024
• 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: Initial
• 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