MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 32+6; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	522033
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Tissue Damage (2104); Not Applicable (3189)
Date of Event	07/27/2018
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.Concomitant medical products: dur dynamic lock ring 56 or 68, 124956000; duraloc const liner 56/68x32, 124216527.
Event or Problem Description
It was reported that according to the doctor, patient had a pseudo tumor issue from wear between head and stem.Patient has been previously revised by other surgeons for similar issues.Did a poly head swap.Cup and stem were fine.No other issues to report.Doi: unknown; dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 7808356
• Report Number: 1818910-2018-67452
• Device Sequence Number: 1469049
• Product Code: JDI
• UDI-Device Identifier: 10603295170839
• UDI-Public: 10603295170839
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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 Catalogue Number: 522033
• Device Lot Number: 8251481
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention