MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM M HEAD 36MM +9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-34-000
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information 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 or Problem Description
Medical records received.After review of medical records, the patient represent with increase pain and discomfort.Cobalt and chromium levels were elevated, a metal subtraction mri showed a large fluid collection, consisted with adverse tissue reaction.The patient was then revised for failed right metal on metal tha.Operative notes reported that there was about 60 cc of graying fluid emanated from what appeared to be a pseudotumor consistent with adverse tissue reaction.Some necrotic appearing material was debrided.There was some evidence of membrane formation at the metal interfaces consistent more with metal on metal reaction vs polyethylene osteolysis.There was a significant amount of blackish corrosion at the female portion of the femoral head.There was some corrosion on the taper.Doi: (b)(6) 2009; dor: (b)(6) 2019 right hip.
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.Initial reporter occupation: lawyer.
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.

• Brand Name: S-ROM M HEAD 36MM +9
• 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
• MDR Report Key: 10599811
• Report Number: 1818910-2020-21058
• Device Sequence Number: 11564481
• Product Code: JDI
• UDI-Device Identifier: 10603295033523
• UDI-Public: 10603295033523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2010
• Device Model Number: 1365-34-000
• Device Catalogue Number: 136534000
• Device Lot Number: 1969975
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 11/04/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/05/2020; 11/04/2020
• 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: PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; S-ROM*SLEEVE PRX ZTT, 14B-LRG; SROM*STM ST,30+4L NK,14X09X130; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; S-ROM*SLEEVE PRX ZTT, 14B-LRG; SROM*STM ST,30+4L NK,14X09X130
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR