MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS SO 13.0; PROSTHESIS HIP

Catalog Number 51-100130

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the labeling on taperloc stem box did not specify that it was a standard fit instead of a reduced distal fit.Stem was implanted and patient experienced a femur fracture that was corrected with the use of cables.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.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Review of the products determined that no failure was found with the device as the products are within specifications.Review of the master labels for the standard fit and reduced distal fit found the products are labeled appropriately.As a result of a user error, the incorrect implant was implanted, which caused the patient's bone to fracture, which was resolved with cables.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: TPRLC 133 FP TYPE1 PPS SO 13.0
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12041369
• MDR Text Key: 257447826
• Report Number: 0001825034-2021-01857
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304498211
• UDI-Public: (01)00880304498211(17)300309(10)6751939
• Combination Product (y/n): N
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-100130
• Device Lot Number: 6751939
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention