MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM HEAD FEMORAL COCR 32+9; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	87-5956
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/22/2020
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
Clinical adverse event received for dislocation - initial.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Treatment: "resume precautions" date of implant: (b)(6) 2020, date of event: (b)(6) 2020, (right hip).
Event or Problem Description
Procedure notes (b)(6) 2020 indicate the patient received a right total hip closed manipulation and reduction under anesthesia due to dislocation.The procedure was completed without indication of complication by the surgeon.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Provided x-ray images have been reviewed.A dislocation event is not depicted in any of the images.No evidence of a product problem is identified.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: g1.

• Brand Name: S-ROM HEAD FEMORAL COCR 32+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: 10993485
• Report Number: 1818910-2020-26818
• Device Sequence Number: 702223
• Product Code: JDI
• UDI-Device Identifier: 10603295218869
• UDI-Public: 10603295218869
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K920317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020

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 Model Number: 87-5956
• Device Catalogue Number: 875956
• Device Lot Number: 8731264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 01/11/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 12/17/2020; 01/12/2021
• 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: ALTRX +4 NEUT 32IDX48OD; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 48MM; S-ROM HEAD FEMORAL COCR 32+9; S-ROM*SLEEVE PRX ZTT, 14B-SML; SROM*STM ST,30+4L NK,14X09X130; ALTRX +4 NEUT 32IDX48OD; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 48MM; S-ROM HEAD FEMORAL COCR 32+9; S-ROM*SLEEVE PRX ZTT, 14B-SML; SROM*STM ST,30+4L NK,14X09X130
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 68