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 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01445, 0001825034-2020-01446, 0001825034-2020-01450.

Event Description

It was reported that during investigation of stock, the sterile packaging was damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D4: udi #: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows that the outer sterile cavities have been damaged.Sterility has not been compromised on any of the products.Device history record (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.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.The event is being reviewed through the capa process.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: 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: 9921813
• MDR Text Key: 186750662
• Report Number: 0001825034-2020-01448
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-105120
• Device Lot Number: 3560787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1