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

Device Problem Degraded (1153)

Patient Problems Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Synovitis (2094); Osteolysis (2377); No Code Available (3191)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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

Pinnacle medical record received.After review of medical record, patient was revised to address pain and synovitis.Revision notes stated that a bulging thickened hip capsule was noted.A 10cc of dark red particulate fluid was removed from the joint and dark red brown effusion was evacuated.The head and liner were removed.There was moderate amount of trunnionosis and corrosion of the femoral trunnion.Operative findings noted metallosis with mark effusion, large pseudotumor, and osteolysis.Blood cobalt levels were increasing but less than 7 ppb.Clinic visits noted erosions of proximal femur.Doi: (b)(6) 2006, dor: (b)(6) 2020 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).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.E3 initial reporter occupation: lawyer.

• Brand Name: S-ROM M HEAD 36MM +6
• Type of Device: 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: 10663099
• MDR Text Key: 211049018
• Report Number: 1818910-2020-21958
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033509
• UDI-Public: 10603295033509
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: 1365-33-000
• Device Catalogue Number: 136533000
• Device Lot Number: 2145711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; S-ROM STM STD,36NK,18X13X160; S-ROM*SLEEVE PRX ZTT, 18F-SML
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR