MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR RED/DIST; PROSTHESIS HIP

Model Number N/A

Device Problems Corroded (1131); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices - unk cup, unk femoral head.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10080 and 0001825034-2018-10086.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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.

Event Description

It was reported that the patient underwent revision procedure due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes.Mri suggested some metal debris in this lesion and serum showed metal ions elevated.Second mri suggested metal-on-metal related pseudotumor involving left hip.Pre-op radiographs show a considerable area of osteolysis about the acetabulum.Synovial fluid was clear with slight yellow tinge.Abundant fluid removed from acetabulum about the prosthesis.No evidence to suggest infection.Taper of femoral component showed no evidence of notching.There was minimal evidence of galvanic corrosion which was cleaned using a bovie pad scrubber.Device history record was reviewed and no discrepancies were found.Root cause was 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.

Event Description

It was reported that the patient underwent hip revision surgery approximately 12 years post initial surgery due pseudotumor and elevated metal ions.Head was revised.Irrigation and debridement of pseudotumor and removal of hypertropic synovial tissue, irrigation and debridement of soft tissue and bone were performed.

• Brand Name: TAPERLOC POR RED/DIST
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8054608
• MDR Text Key: 126639212
• Report Number: 0001825034-2018-10082
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

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 Expiration Date: 12/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 12-103209
• Device Lot Number: 280280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 04/03/2019
• Supplement Dates FDA Received: 12/13/2018; 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention