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

Catalog Number 51-145120

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2020

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 # 51-107090/ tprlc mp type 1 / lot # 3201758.Item # 51-102040/ tprlc xp fp /lot # 3455231.Report source: foreign-(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00412, 0001825034-2020-00414.

Event Description

It was reported during inspection of the product at the distributorship, that the sterile packaging was noted to be damaged.There was no patient or hospital involvement.Attempts have been made an no further information has been provided.

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.Reported event was able to be confirmed by visual inspection of the returned products identified the outer carton boxes were damaged, consistent with transit damage.The outer cavities were damaged.The sterility of the products still remains intact.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage.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 MP T1 PPS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9649103
• MDR Text Key: 200195722
• Report Number: 0001825034-2020-00413
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-145120
• Device Lot Number: 6006852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1