MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HYLAMER NEUT 52OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 125112000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The primary surgery was performed via tha about 20 years ago (the date was unknown).It was reported that the removal surgery was performed on (b)(6) 2020 by removing the stem (p/n: 137019000), the cup (p/n: 124752000), the liner (p/n: 124112000) and the head (p/n: 136513000) due to pain which was caused by suspicion of pseudotumor.The surgery was completed, and it was unknown whether there was any surgical delay.The duration of the surgery was about 3 hours.After the surgery, the surgeon confirmed that the pseudotumor occurred, but corrosion like blacking was not seemed at head neck junction.The surgeon requested to investigate whether the corrosion occurred for real.The revision surgery was scheduled on (b)(6) 2020.No further information is available.

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).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:  corrected: h5 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned liner finds nothing outward to suggest a product problem.There is nothing unexpected or unusual for an explanted device after approximately 20 years of service.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 : 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: HYLAMER NEUT 52OD X 28ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10253462
• MDR Text Key: 198536109
• Report Number: 1818910-2020-15450
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K940743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/25/2020

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 Catalogue Number: 125112000
• Device Lot Number: 802720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 08/13/2020; 11/08/2020; 01/29/2021
• Supplement Dates FDA Received: 08/12/2020; 08/14/2020; 11/22/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +8.5 BL; DURALOC 100 SERIES 52MM OD; LOCKING RING; PRO HIP STEM W/PORO SZ 000 RT
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 88