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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision right total hip replacement where several revisions have occurred.The original primary surgeon implanted an ¿esca¿ primary hip replacement with a cement modular neck femoral component and cementless acetabular component with an alumina ceramic on ceramic bearing approximately 20 years ago.The femoral component aseptically loosened over a decade ago and the femur revised to an srom femoral component with a ceramic head.The esca acetabular component was not changed at this time.This revision surgery was undertaken by dr peter.The srom femoral component (from memory and my recollection) fractured approximately five years or more ago and was revised and removed by except for one segment of metal that was pushed distal down the femoral canal, well distal of another new primary srom femoral component and ceramic head.The acetabular component (esca) remained insitu with the alumina ceramic bearing.The revision today entailed revision for instability requiring the changing of the femoral head and removal of the esca alumina ceramic acetabular bearing that was original from the primary surgery.The revision today essentially required the changing of an srom ceramic femoral head to an srom metal head.A constrained liner was implanted (non depuy synthes).No consent has been obtained from the patient or four surgeons in this report to the sharing of information including that contained on this document.The history is only from the recollection of the reporter over a 15 year period.No further information is available.Doi: (b)(6) 2015; dor: (b)(6) 2022; unknown side.
Additional 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.

• Brand Name: DELTA CER HEAD 11/13 32MM +0
• Common Device Name: 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: 13928525
• Report Number: 1818910-2022-05613
• Device Sequence Number: 6251706
• Product Code: LZO
• UDI-Device Identifier: 10603295033400
• UDI-Public: 10603295033400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1365-32-210
• Device Catalogue Number: 136532210
• Device Lot Number: 8042154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/10/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENT MFG AND PRODUCT NAME UNKNOWN; DELTA CER HEAD 11/13 32MM +0; S-ROM*SLVE ZTTOVSZ 22F-LRG20ID; SROM*STM ST,36+8L NK,20X15X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male