MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/30/2020
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
It was reported by the surgeon that the patient was complaining of hip pain.Patient was unable to tell who performed the original procedure and where it was performed.After reviewing the patients xrays, surgeon felt the acetabular components needed to be revised.The femoral components seemed to be stable and appropriately positioned.The acetabulum was an old srom super cup.I was unable to read item and lot numbers on the implants.Unable to identify the cup, liner and peripheral screw sizes.Once the cup was removed, surgeon reamed the acetabulum to a 58, and implanted a 58mm multi-hole gription cup.A neutral 58x36mm liner was implanted and a 36mm +6 head was trailed.The hip was found to be stable and of appropriate length, so the real head was opened and implanted.The closing process began.Original implant date unknown.No surgical delay.Doi: unknown; dor: (b)(6) 2020; left 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 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 : a device history record (dhr) review, was not possible because the required lot code(s) was not provided.

• Common Device Name: 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: 10819538
• Report Number: 1818910-2020-24393
• Device Sequence Number: 11793340
• Product Code: JDI
• UDI-Device Identifier: 10603295170808
• UDI-Public: 10603295170808
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 52-2029
• Device Catalogue Number: 522029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: PERIPHERAL SCREWS; PERIPHERAL SCREWS; S-ROM*HEAD FEMORAL COCR 28+6; SROM LINER; SROM SUPER CUP; PERIPHERAL SCREWS; PERIPHERAL SCREWS; S-ROM*HEAD FEMORAL COCR 28+6; SROM LINER; SROM SUPER CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR