MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR RED/LAT 17.5X155; PROSTHESIS HIP

Model Number N/A

Device Problems Corroded (1131); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: m2a-magnum mod hd sz 58mm # item 157458 lot 832880, m2a-magnum pf cup 64odx58id # item us157864 lot 792860, m2a-magnum 52-60mm tpr insrt-6 # item 139264 lot 348620.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02174.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 was being revised approximately seven years post initial surgery due to pain.During revision, the femoral head could not be disassociated from the stem with noted trunnionosis.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes.Revision op notes were reviewed and patient was revised due to complications of pain and elevated ion levels.During the revision surgery it was identified stem was unable to disengage from the taper.An osteotomy was done to remove the stem.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

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

• Brand Name: TAPERLOC POR RED/LAT 17.5X155
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8603683
• MDR Text Key: 144826434
• Report Number: 0001825034-2019-02175
• 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: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 13-103209
• Device Lot Number: 479640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1