MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TAPERLOC STEM PROSTHESIS, HIP

Model Number N/A

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Event Description

It was reported the patient experienced femoral loosening at 422 days postop and was subsequently revised. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4). Report source: ennin k. A. , elsharkawy k. A. , dasgupta s. , emerson r. H. (2021) cemented femoral stem fixation through the anterior approach has fewer early complications than cementless fixation. Bone joint j 2021;103-b (7 supple b):33¿37. Https://doi. Org/10. 1302/0301-620x. 103b7. Bjj-2020-2230. R1 customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device location unknown.

• Brand Name: UNKNOWN TAPERLOC 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: 13719721
• MDR Text Key: 287832369
• Report Number: 0001825034-2022-00515
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: NI

Patient Treatment Data

Date Received: 03/10/2022 Patient Sequence Number: 1