MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M / L TAPER G2 MODULAR FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00877503202, bioloxâ® delta ceramic femoral head, 2903380, 00784801300, modular neck p 12/14 neck taper, 63609979, 00620005022, shell porous with cluster holes 50 mm, 63369355, 00630505032, liner standard 32 mm, 63762622.Provided radiograph shows a femoral fracture, however, since the radiograph could not be confirmed as for this patient for this event, the reported event was unable to be confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required 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.Discarded.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised due to periprosthetic fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: M / L TAPER G2 MODULAR FEMORAL STEM
• 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: 7142830
• MDR Text Key: 95638090
• Report Number: 0001822565-2017-08651
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771300700
• Device Lot Number: 63665881
• Other Device ID Number: 00889024132610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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: 70 YR
• Patient Weight: 74