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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Decreased Sensitivity (2683)

Event Date 04/30/2022

Event Type  Injury  

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 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 Description

No additional event information to report at this time.

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
• Type of Device: 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
• MDR Text Key: 292367248
• Report Number: 0002648920-2022-00129
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024498785
• UDI-Public: (01)00889024498785(17)251030(10)64816019
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/01/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention