MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM M HEAD 36MM +6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-33-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had bilateral total srom hips.She was revised due to infection in both hips.Lot number on the cup was damaged during explant and unretrievable.The left side was revised with head and liner exchange.There was no surgical delay.Doi- unknown.Dor- (b)(6) 2022.Affected side- left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 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.No device(s) associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional related reports against the provided product code and lot number combination(s) for infection.Since allegation is not related to manufacturing, mre will not be performed.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; 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: S-ROM M HEAD 36MM +6
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16101815
• Report Number: 1818910-2023-00459
• Device Sequence Number: 6262315
• Product Code: LPH
• UDI-Device Identifier: 10603295033509
• UDI-Public: 10603295033509
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 1365-33-000
• Device Catalogue Number: 136533000
• Device Lot Number: 2645602
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2008
• 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: PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +6
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 95 KG