MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON 10D 58 OR 70ODX28ID; HIP POLY ACETABULAR LINERS

Catalog Number 124158025

Device Problem Naturally Worn (2988)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  Injury  

Event Description

It was reported that the patient has a hip revision booked.The patient had a duraloc cup and eduron poly and duraloc cup which was implanted (b)(6) 2008, right side.The reason for revision is due to poly wear, and patient looks to be articulating metal on metal now.Patient currently has an enduron 28/58 lipped poly, and a duraloc 100 series cup 58mm.

Manufacturer Narrative

Product complaint # (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).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the 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 or product id numbers are 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.

Event Description

Additional information received indicates that the locking ring was also removed as standard with this revision and there were no adverse consequences noted.

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: d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H4.

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 from the sales rep: a.No surgical delay.B.The revision was cancelled 17/10 as the patient had a medical event.They might book this in for next week.C.Surgeon said that it looks like they are now articulating with the metal head on the cup.Poly looks to be completely worn away.If the stem is loose due to poly lysis it might need to be revised too.

Event Description

Additional information was received and stated.Yes.The revision was performed on 28/11.The liner was explanted on 28/11.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: according to the information received.(b)(6) notified me today, that he has a hip revision booked for tuesday [date].The patient had a duraloc cup and eduron poly and duraloc cup.Which was implanted [date].Right side.Patient was [age] old at the time.(b)(6) told me, that the reason for revision is, due to poly wear and he said, the patient looks to be articulating metal on metal now.Unsure of the lot number of the poly or cup.I'll try get this next week at the revision if possible.They currently, have an enduron 28/58 lipped poly and a duraloc 100 series cup 58mm.The product was not returned to depuy synthes.However, photos were provided for review.The photo investigation revealed, that enduron 10d 58 or 70odx28id had worn patterns in polyethylene material surface.Additionally, more damage was found at the edge of the liner.Most likely, to happen, during extraction process.With evidence provided, it is not possible, to establish a potential cause.Since, the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed.As the observed, condition of the enduron 10d 58 or 70odx28id would contribute to the complained device issue.Based on the investigation findings, the cause is not established.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ENDURON 10D 58 OR 70ODX28ID
• Type of Device: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17957000
• MDR Text Key: 325936401
• Report Number: 1818910-2023-21265
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K944538
• 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: 10/18/2023

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: 124158025
• Device Lot Number: 1230040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 11/10/2023; 11/28/2023; 12/13/2023; 01/05/2024
• Supplement Dates FDA Received: 10/24/2023; 11/12/2023; 12/08/2023; 12/18/2023; 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2004
• 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: DUR DYNAMIC LOCK RING 58 OR 70; DURALOC 100 SERIES 58MM OD; STRYKER HEAD (COMPETITOR); STRYKER STEM (COMPETITOR)
• Patient Outcome(s): Required Intervention
• Patient Sex: Male