MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ADAPTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Separation Failure (2547); Difficult or Delayed Separation (4044)

Patient Problems Pain (1994); No Information (3190)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown.Item #: unknown taperloc stem lot #: unknown.Item #: unknown m2a magnum cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.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: 0001825034-2020-01268 stem.0001825034-2020-01270 head.0001825034-2020-01271 cup.

Event Description

It was reported that a patient underwent a the approximately twelve years prior.Patient had preoperative pain that surgeon believed to be related to metal on metal articulation.Plan was to remove current head and taper adapter, and place a new head with titanium sleeve and dual mobility bearing.Surgeon exposed femoral head prosthesis via direct anterior approach.A bone tamp was used to attempt to disengage head and adapter from the stem.After approximately 30 minutes, the head was successfully removed from the adapter.However the adapter remained attached to the stem despite repeated high impact blows directly to the adapter.A high speed burr was then used to attempt to remove a section of the adapter, in the hopes that this would allow for the adapter to be removed.This was also unsuccessful.Approximately two hours into the procedure, the decision was made to revise the femoral stem.Stem was successfully removed with no impact to patient.The patient retained the acetabular cup.Dual mobility devices were implanted.In addition, a competitor stem was implanted.Attempts have been made and no further information has been provided.

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 unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN ADAPTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9887929
• MDR Text Key: 189776672
• Report Number: 0001825034-2020-01269
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention