MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 00631004832 liner 10 degree elevated rim 32 mm i.D.Lot#: 64151274.Catalog#: 00620004822 shell porous with cluster holes 48 mm o.D.Lot#: 64044652.Catalog#: 00625006530 bone screw self-tapping 6.5 mm dia.30 mm length lot#: 64124015.Catalog#: 00625006525 bone screw self-tapping 6.5 mm dia.25 mm length lot#: 64117736.Catalog#: 00785801157 sleeve vh proximal centralizer size 11 assemble with bone cement lot#: 63410857.Catalog#: 00785901100 centralizer 11 mm o.D.Lot#: 63552469.Catalog#: 9632-003-000 femoral cement restrictor lot#: 017081335.Catalog#: 3105-040 smartest gmv endurance gentamicin bone cement lot#: 8690368.Report source: foreign: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00021.
Event or Problem Description
It was reported that approximately 10 months post implantation, the patient fell from bed and experienced a dislocation.It was further reported that the patient underwent a closed reduction procedure on an unknown date due to recurrent dislocations.The patient has been indicated for a revision procedure using a custom device; however, no revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 the event was confirmed with radiographs received.Radiographs were provided and reviewed by a health care professional.Review of the radiographs identified the following: dislocation of the right hip arthroplasty.No further evaluation could be performed with the images provided.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11292161
• Report Number: 0002648920-2021-00022
• Device Sequence Number: 11969740
• Product Code: LPH
• UDI-Device Identifier: 00889024144675
• UDI-Public: (01)00889024144675(17)280831(10)64123511
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: N/A
• Device Catalogue Number: 00801803202
• Device Lot Number: 64123511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 60