MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Pain (1994); Synovitis (2094); Discomfort (2330); Joint Laxity (4526)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Revision procedure for patient experiencing pain.Xray revealed worn polyethylene liner.Operative notes indicated discomfort, loud squeaking, polyethyline fracture, fractured worn polyethyline with subluxation out of the ring fixation, wear debris and synovitis.Provided x-ray image and explanted device photographs confirms a rim fracture of the poly liner.Review of the x-ray and the femoral head photo finds sufficient evidence of a disassociation event.Doi: unknown.Dor: (b)(6) 2021.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.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 device and provided images found evidence to support the reported implant noise.Depuy considers the investigation closed.Should additional info be received, 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11685935
• MDR Text Key: 260684305
• Report Number: 1818910-2021-08188
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 8303763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; CORAIL AMT COLLAR SIZE 11; PINN 100 W/GRIPTION 48MM; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR