MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER 28 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Hyporesponsive to stimuli (2683)
Date of Event	04/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Source: (b)(6).Concomitant medical products: catalog number:110031010, lot number: 65254480, brand name: vivacit-e dual mobility.Multiple reports were submitted along with this report 0001822565-2022-01489.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was revised due to dislocation and disassociation of the bearing which was free floating in the joint causing loose of sensation in the hip approximately 20 days post implantation.Additional information on the reported event is unavailable.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code mechanical (g04) - head.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: image one demonstrate superior dislocation.Image two demonstrates polyethylene wear.Image three demonstrates possible metallosis.Image three also demonstrates a small metallic focus near the greater trochanter, possibly loose body.Visual examination of the returned head shows no damage from previous uses.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.A summary of the investigation was requested and sent to the reporter.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.

• Brand Name: FEMORAL HEAD 12/14 TAPER 28 MM
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14462116
• Report Number: 0002648920-2022-00129
• Device Sequence Number: 14578915
• Product Code: KWY
• UDI-Device Identifier: 00889024498785
• UDI-Public: (01)00889024498785(17)251030(10)64816019
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 802202802
• Device Lot Number: 64816019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown