MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,30 NK,12X07X115; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523207
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2003, the patient underwent the primary surgery with the implants in question.The surgery was completed successfully without any surgical delay.It is unknown whether the implants other than reported products used in the primary surgery are jj products or not.On an unknown date, dislocation and stem sinking were confirmed.The cause of the loosing was unknown.Therefore, the revision surgery is scheduled for (b)(6) 2024, at another hospital.The cup side is also poorly placed, and all implants will be replaced.No further information is available.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19690340
• Report Number: 1818910-2024-14746
• Device Sequence Number: 7155925
• Product Code: LZO
• UDI-Device Identifier: 10603295170938
• UDI-Public: (01)10603295170938(10)1113990(17)080529
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/08/2024

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 Expiration Date: 05/29/2008
• Device Catalogue Number: 523207
• Device Lot Number: 1113990
• 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: 06/28/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2003
• 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: CREATED IN ERROR.; S-ROM*CUP ACE,ZTT-2 L32,54DP.; S-ROM*HEAD FEMORAL COCR 26+6.; S-ROM*LINR LSER, 0 DEG, 26MM.; S-ROM*SCREW,5.0MM DIA,25 MM LG.; S-ROM*SCREW,5.0MM DIA,25 MM LG.; S-ROM*SCREW,6.5MM DIA,20MM LG.; S-ROM*SCREW,6.5MM DIA,20MM LG.; S-ROM*SCREW,6.5MM DIA,25MM LG.; S-ROM*SLEEVE PRX ZTT, 12B-SML.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown