MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-720

Device Problem Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2016

Event Type  Injury  

Event Description

Update ad 22 nov 2021 pf and medical records received. Pfs has no new allegation. After review of medical records patient was revised was due to recurrent instability. Intra op findings and confirm during revision that slightly retroverted acetabulum component. Instability at flexion to 70, internal rotation of 30. Upon incision, a 7cm of scar excising that through the dermal layer. Closely inspected the acetabulum, there was actually a fairly large cyst posteriorly full of metallic debris. Doi: (b)(6) 2016 - dor: (b)(6) 2016 (right hip).

Manufacturer Narrative

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

• Brand Name: DLT TS CER HD 12/14 32MM +5
• 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
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12884050
• MDR Text Key: 282970866
• Report Number: 1818910-2021-26428
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: 1365-32-720
• Device Catalogue Number: 136532720
• Device Lot Number: 8201691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/29/2021 Patient Sequence Number: 1

Treatment

ALTRX +4 10D 32IDX50OD; DLT TS CER HD 12/14 32MM +5