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

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part# unknown/ unknown head/ lot # unknown; part# unknown/ unknown stem / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -04116.

Event Description

It was reported that patient underwent left hip revision surgery approximately 14 years post implantation due to elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was able to be confirmed by the review of medical records/radiographs.Review of the available records identified the elevated metal ions secondary to left metal-on-metal total hip arthroplasty, spinal anesthesia.Ebl 100 ml, stem and acetabulum well fixed.The head was removed, the trunnion of the prosthesis appeared intact, did not appear to have any wear, did not appear to have any metalosis or obvious fretting of the trunnion.The acetabular component was visualized and noted to be intact.There did not appear to be any etching or subluxing of the component.It appeared smooth as well polished.No intra-operative complications identified.Device history record (dhr) reviewed was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is 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.

Event Description

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

• Brand Name: UNKNOWN CUP
• 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: 10837103
• MDR Text Key: 216177915
• Report Number: 0001825034-2020-04115
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention