MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC COMPLETE PRIMARY FEMORAL; PROSTHESIS, HIP

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - pn: us157846 ln: 119580 m2a-magnum pf cup 46odx40id.Pn: 650-1055 ln: 825270 cer bioloxd option hd 28 mm.Pn: ep-200146 ln: 149230 act artic e1 hip brg 28 x 40 mm.No product was returned; therefore visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00017 and 02425.Remains implanted.

Event Description

It was reported patient is experiencing pain, leg length discrepancy, and difficulty walking approximately two years post-implantation.Patient reported incorrect size taper was implanted during initial procedure.The patient indicates future revision; however, no revision procedure has been reported to date.No further information has been reported at this time.

• Brand Name: TAPERLOC COMPLETE PRIMARY FEMORAL
• 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: 7171865
• MDR Text Key: 96622937
• Report Number: 0001825034-2018-00140
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 51-101070
• Device Lot Number: 3282804
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 78