MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM STM STD 36+12L 15X20; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number	56-3620
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Clinical notification received for revision of left total hip to address metallosis date of implantation: (b)(6) 2007.Date of revision: (b)(6) 2021 (left hip) leading up to the revision operation on (b)(6) 2021, the surgeon noted on examination he could hear a little ratcheting when the patient hyperflexes.Cobalt and chromium levels were 15 and 2.5.Unit of measure not given.Mri findings indicated a bit of an adverse reaction to metal debris as well as a little bit of lysis.The surgeon indicated the main issue was the metal debris without significant lysis.On (b)(6) 2021, the patient underwent a left hip revision to address metallosis, ratcheting, and increased discomfort.The surgeon noted there was a large rent directly posteriorly in the capsule.Also, there was mild taper corrosion that was cleaned.The asr components were revised with a depuy gription shell, altrx polyethylene liner, three dome screws, and depuy cobalt chrome head.Treatment: revision of the asr cup, asr femoral head, and asr femoral sleeve; s-rom femoral stem and s-rom proximal sleeve retained.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of provided x-ray images finds nothing indicative of a product problem.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM STM STD 36+12L 15X20
• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12016640
• Report Number: 1818910-2021-12876
• Device Sequence Number: 14513973
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 56-3620
• Device Catalogue Number: 563620
• Device Lot Number: 2386760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20; ADAPTER SLEEVE 11/13 +3; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM STM STD 36+12L 15X20
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 75