MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP MOLD STEM W/REINF 11X200; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Report source: foreign: country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01947, 0001822565-2020-01623.

Event Description

It was reported the patient underwent initial tha.Subsequently, the patient suffers from unknown post operative complications approximately 1 year later.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi# (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have attributed to the event.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.

• Brand Name: HIP MOLD STEM W/REINF 11X200
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10066411
• MDR Text Key: 193934801
• Report Number: 0001825034-2020-01948
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K161166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: N/A
• Device Catalogue Number: 431196
• Device Lot Number: 144790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET CEMENT MOLD CAT#431181 LOT#884490; BIOMET CEMENT MOLD CAT#431186 LOT#656310
• Patient Outcome(s): Other