MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Degraded (1153); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Reaction (2414); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03010.

Event Description

It was reported that patient underwent a right hip revision approximately 13 years post implantation due to pain and dissociation of the head from the stem.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.An updated investigation is in process and a follow-up mdr will be submitted upon completion.

Event Description

It was reported that patient was standing from the couch resulting in feeling a painful pop after an unknown amount of time post operatively.Subsequently, the patient underwent a right hip revision approximately 13 years post implantation due to disassociation of the head from the stem component.During the surgery, significant wear was noted on the trunnion and there was significant damage to the poly and locking mechanism of the shell.All components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and x-rays received.Review of the available records identified the patient underwent an initial right total hip arthroplasty due to osteoarthritis.The patient was later revised due to failed hip arthroplasty.Post op office visit records stated that the patient sat on the couch and was unable to walk upon standing, using crutches.X-ray review revealed dissociation of the trunnion from the patient's ceramic femoral head.Further x-ray review revealed the cup is slightly lateralized, no clear evidence of loosening, and no adjunct screw fixation.The head appears to be completely disassociated from the trunnion, notable deformity of the trunnion with what appears to be a significant notch within the neck of the stem, metal on poly articulation, stem well-fixed, no evidence of radiolucency or stem subsidence, no fractures.During the revision procedure, the head was found to be disassociated from the trunnion.There was significant damage and remodeling of the trunnion.The trunnion itself was worn but not fractured.Metallosis was present in the joint.There was significant damage to the poly liner and the shell's locking ring mechanism.All zimmer biomet components were replaced with competitor's products.No other findings/complications were noted.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  lot identification is necessary for review of device history records, lot identification was not provided.Root cause remains unchanged.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 STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10437247
• MDR Text Key: 203877061
• Report Number: 0001822565-2020-03009
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00801803603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 04/14/2021; 10/04/2021; 12/06/2021
• Supplement Dates FDA Received: 01/04/2021; 04/29/2021; 11/01/2021; 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK CUP.; UNK LINER.; UNK STEM.; UNK CUP; UNK LINER; UNK STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG