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 Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Joint Dislocation (2374); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #:(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
(b)(6).Clinical notification received for revision of right total hip to address adverse local tissue reaction (altr) date of implantation:(b)(6) 2006.Date of revision: (b)(6) 2021.(right hip) the medical records have been reviewed to identify patient harms/product failures.On (b)(6) 2021, the patient underwent a right hip revision to address dislocation, synovitis, pain, metallosis, osteolysis, pseudotumor, and corrosion of the stem trunnion.The surgeon indicated after removal of the head from the stem there was corrosion compatible with metallosis, the corrosion was cleaned off the trunnion.There was extensive superior iliac bone loss.The central dome screw was removed from the well-fixed cup.There is no indication the screw was replaced.Removal of the metal liner demonstrated extreme backside cobalt chrome metallosis.Pseudotumor invaded the abductor musculature and the short external rotators of the femur, and extensive osteolsysis of the medial anterior and posterior proximal porous sleeve of the s-rom component.However, there was rigid fixation distally and laterally and the stem was solid in the femur.The femoral head and acetabular liner were revised.The central dome screw was removed but not replaced.The acetabular cup, hole eliminator, femoral stem, and femoral sleeve were retained.The patient was revised with a depuy pinnacle gvf polyethylene constrained acetabular liner and depuy s-rom revision ceramic femoral head.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

• 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
• MDR Report Key: 11984409
• Report Number: 1818910-2021-12428
• Device Sequence Number: 4345373
• Product Code: LPH
• UDI-Device Identifier: 10603295033509
• UDI-Public: 10603295033509
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• 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): 05/19/2021

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: 1365-33-000
• Device Catalogue Number: 136533000
• Device Lot Number: 2122170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; S-ROM*SLEEVE PRX ZTT, 20F-LRG; SROM*STM ST,36+8L NK,20X15X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 102