MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASPHERE M SPEC 11/13 36 +0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	1365-31-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was revised for painful right tha, metallosis, and mechanical loosening of the cup.Intra-operative notes reported that there was excess fluid in the joint.The cup was found to be loosed and there was softening of acetabular bone in the medical wall region.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.

• Brand Name: ASPHERE M SPEC 11/13 36 +0
• 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: 10368647
• Report Number: 1818910-2020-17637
• Device Sequence Number: 3371206
• Product Code: JDI
• UDI-Device Identifier: 10603295033370
• UDI-Public: 10603295033370
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 1365-31-100
• Device Catalogue Number: 136531100
• Device Lot Number: 2920252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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 6.5MMX30MM; PINN SECTOR W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM*SLEEVE PRX ZTT, 22B-SML; SROM STM STD 36+12L 17X22; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM*SLEEVE PRX ZTT, 22B-SML; SROM STM STD 36+12L 17X22
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 61