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

Model Number N/A

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

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02462.

Event Description

It was reported the patient underwent right hip monopolar hemiarthroplasty.Subsequently, the patient reported severe pain despite surgical intervention.Review of x-rays showed subsidence of the femoral stem with disassociation of the stem and head.During the revision, the stem was found grossly loose and mobile within the canal.The patient was revised to a bipolar hemiarthroplasty approximately 15 days later.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a monopolar hemiarthroplasty.The patient reported severe pain despite the surgical intervention at the follow up.Review of the x-ray showed subsidence of the stem with disassociation of the stem and head.It was confirmed by the surgeon during the revision that the head and stem were disassociated.The stem was loose and mobile in the canal.The bone quality was good and no fractures appreciated.It was decided to broach to a size 16 stem, which had better fit but a little bit of rotational instability.The size 16 was the largest size that would allow an extended neck.The bipolar head was placed and the stem cemented.No complications were noted.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.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 Description

No further event information available at the time of this report.

• Brand Name: ENDO FEMORAL HEAD 12 / 14 TAPER
• 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
• MDR Report Key: 12405795
• MDR Text Key: 269343717
• Report Number: 0002648920-2021-00243
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00889024362130
• UDI-Public: (01)00889024362130(17)310117(10)64854904
• Combination Product (y/n): N
• PMA/PMN Number: K955473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: 00781805000
• Device Lot Number: 64854904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75