MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DELTA CER HEAD 11/13 32MM +6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136532230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the surgeon revised a 18x13 30+4 s-rom stem and a 50mm pinnacle cup.The pinnacle cup was determined, to be implanted too flat and anteverted, during a previous operation, which had led to the 32mm +6 ceramic breaking.The s-rom stem was explanted and a 18x13 36+12 stem was implanted.The cup was explanted and a 58mm revision cup with a 36mm ceramic head was implanted.There was no surgical delay.The new stem provided good stability.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained, that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device [136532230/ 4111232] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of aby pre-existing material defect.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.If additional information is made available, the investigation will be updated as applicable.¿ device history lot: a manufacturing record evaluation was performed for the finished device [136532230/ 4111232] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of aby pre-existing material defect.Device history review: a manufacturing record evaluation was performed for the finished device [136532230/ 4111232] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of aby pre-existing material defect.

• Brand Name: DELTA CER HEAD 11/13 32MM +6
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20693867
• Report Number: 1818910-2024-23861
• Device Sequence Number: 8584945
• Product Code: LZO
• UDI-Device Identifier: 10603295033424
• UDI-Public: (01)10603295033424(17)280229(10)4111232
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 136532230
• Device Lot Number: 4111232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female