MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC XR T1 PPS; PROSTHESIS, HIP

Catalog Number 51-105120

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.(b)(4).Concomitant medical products: item # 51-104150/ tprlc 133 t1 pps ho / lot # 3838102.Item# 51-105150/ tprlc xr t1 pps / lot # 2867459.Item# 51-105150/ tprlc xr t1 pps / lot# 2867456.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01819, 0001825034-2020-01820, 0001825034-2020-01824.

Event Description

It was reported during circulation of product, sterile packaging was found to be damaged.There was no patient involvement.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.Evaluation of the returned products confirmed the sterile packaging blister is damaged.Therefore, the reported event is confirmed and sterility of the product is intact.Dhr was reviewed and no discrepancies relevant to the reported event were found the root cause of the reported event it likely to be damage during transit.The event is being reviewed through the capa process.The device evaluation found no reportable malfunction and the event did not contribute to 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.

• Brand Name: TAPERLOC XR T1 PPS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10013759
• MDR Text Key: 200814775
• Report Number: 0001825034-2020-01822
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 51-105120
• Device Lot Number: 2867321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.