MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 UNK HIP FEMORAL STEM CORAIL; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3618
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646); Unspecified Tissue Injury (4559)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Corail pinnacle with ceramic bearings revised due to unknown reason of osteolysis.Some marking was seen on the cup and head, and some bone loss observed in the acetabulum and femur.Revised to an s-rom with g7 dual mobility cup, surgeon was aware that this is off license usage.No products codes are available for explanted implants as no records.Surgeon deemed that the cup looked stable, but the stem exhibited signs of loosening.Radiographically these looked to have been implanted in the correct orientation.No implants are available as these have been sent to royal perth retrivals.
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).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.
Event or Problem Description
Affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15924039
• Report Number: 1818910-2022-24386
• Device Sequence Number: 14766948
• Product Code: JDI
• UDI-Device Identifier: 10603295178224
• UDI-Public: 10603295178224
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 56-3618
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Device Lot Number: 9653660
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/19/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/22/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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: DELTA CER HEAD 11/13 28MM +3; S-ROM*SLEEVE PRX ZTT, 18D-LRG; UNK HIP FEMORAL SLEEVE SROM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown