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

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/07/2021

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 256717217
• Report Number: 1818910-2021-12876
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 56-3620
• Device Catalogue Number: 563620
• Device Lot Number: 2386760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 75