MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 28+6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2029
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Synovitis (2094); Joint Dislocation (2374); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/13/2021
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 hip dislocation and polyethylene liner wear.Date of implantation: (b)(6) 2002.Date of revision: (b)(6) 2021.(right hip).Treatment: revision of acetabular liner and femoral head.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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
Operative notes were reviewed and indicated that on (b)(6) 2021, the patient had a right revision total hip to address dislocation, instability, eccentric polyethylene wear.During the revision the surgeon observed effusion, foreign body synovitis.There was some corrosion on the trunnion.The femoral head and liner were revised.Depuy components were used during this procedure.
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 error in manufacture or material is not suspected to have contributed to the reported allegations after this length of time implanted.A complaint database search and/or device manufacturing (mre) review will not be performed even when lot information is known.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12752507
• Report Number: 1818910-2021-24425
• Device Sequence Number: 11902180
• Product Code: JDI
• UDI-Device Identifier: 10603295170808
• UDI-Public: 10603295170808
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: 52-2029
• Device Catalogue Number: 522029
• Device Lot Number: XYH-70
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/30/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/11/2021; 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: APEX HOLE ELIM POSITIVE STOP; PINN MAR NEUT 28IDX60OD; PINNACLE 100 ACET CUP 60MM; S-ROM*HEAD FEMORAL COCR 28+6; S-ROM*SLEEVE PRX ZTT, 22B-LRG; SROM*STM ST,36+8L NK,22X17X165; APEX HOLE ELIM POSITIVE STOP; PINN MAR NEUT 28IDX60OD; PINNACLE 100 ACET CUP 60MM; S-ROM*HEAD FEMORAL COCR 28+6; S-ROM*SLEEVE PRX ZTT, 22B-LRG; SROM*STM ST,36+8L NK,22X17X165
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown