MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 11/13 32MM +0; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-210

Device Problem Fracture (1260)

Patient Problems Fall (1848); Muscular Rigidity (1968); Pain (1994)

Event Date 02/24/2022

Event Type  Injury  

Event Description

Revision completed due to pain and increasing stiffness after suffering a fall.Preoperative images indicated a fractured femoral head.Upon exposure, the femoral head was confirmed to be fractured.Approximately 6 large fragments and 5-7 smaller fragments were retrieved from the acetabulum and surrounding soft tissue.The liner was also found to be damaged, although still securely locked in the shell.The liner was removed and the cup was examined for damage.After both cup and trunion were found to be suitable, trial parts confirmed the stability of the components and the definitive implants were implanted.There were not any unexpected delays during the procedure.Doi: (b)(6) 2012; dor: (b)(6) 2022; affected side: right hip.

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.

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.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 is received at a later date, the investigation will be updated as applicable.

Event Description

Additional information received indicated that the liner had experienced significant wear as the trunnion of the stem had begun to penetrate the bearing surface (meaning the hip stayed located after head fracture and trunnion burrowed a hole in liner).

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.

• Brand Name: DELTA CER HEAD 11/13 32MM +0
• Type of Device: S-ROM FEMORAL HEADS (11/13) : 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: 13721364
• MDR Text Key: 286937348
• Report Number: 1818910-2022-04453
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033400
• UDI-Public: 10603295033400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

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 Model Number: 1365-32-210
• Device Catalogue Number: 136532210
• Device Lot Number: 3470907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 03/28/2022
• Supplement Dates FDA Received: 03/23/2022; 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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: ALTRX NEUT 32IDX52OD.
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female