MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 15X150MM 0MM T1; PROSTHESIS HIP

Catalog Number 51-104150

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) customer has indicated that the product is in the process of being returned to zimmer biomet.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 51-105150/ tprlc xr t1 pps / lot # 6222403.Item # 51-105140/ tprlc xr t1 pps/lot # 3595176.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00684.0001825034 -2021 -00687.

Event Description

It was reported that the investigation of product at the distributorship, debris was found inside the sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d9; g3; h2; h3; h4; h6 complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed the following: lot #3838103: sterile packaging blister is damaged.The root cause of the reported event can be attributed to transit damage and packaging design deficiency.The event is being addressed through the capa process.The device evaluation found the product to be conforming and sterility not compromised.Further, the event did not contribute to a serious injury; therefore, this would not be considered a reportable event.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.

Event Description

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

• Brand Name: TPRLC 133 T1 PPS HO 15X150MM 0MM T1
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11448112
• MDR Text Key: 244780309
• Report Number: 0001825034-2021-00685
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-104150
• Device Lot Number: 3838103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1