MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM PROSTHESIS, HIP

Catalog Number 00771301000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # 00625006525 / bone screw/ lot # 62466422. Part # 00625006525 / bone screw/ lot # 62466422. Part #00784802300 modular neck/ lot # 62335280. Part # 00801803202 / femoral head / lot # 62498217. Part # 62025020 / shell / lot # 62064875. Part # 63105032 / liner/ lot # 62449618. Part # unknown / femoral head allograft/ lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2020 -00277. 0002648920 -2020 -00276. 0001822565 -2020 -01866. 0001822565 -2020 -01865.

Event Description

It was reported that during a diagnostic radiology 4 years post implantation that there was bending of the screws of the left superior acetabulum. Slight leg length discrepancy, with the left leg longer than the right (1cm). No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 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: 10091960
• MDR Text Key: 194953159
• Report Number: 0001822565-2020-01884
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/27/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/31/2017
• Device Catalogue Number: 00771301000
• Device LOT Number: 60743574
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/08/2007
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 05/27/2020 Patient Sequence Number: 1