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

Catalog Number	51-102050
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional 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 concomitant medical products: item# 51-105140/ tprlc xr t1 pps / lot # 6222400, item # 51-101060/ tprlc 133 fp type1 pps/lot # 6114646.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00514, 0001825034-2021-00515.
Event or Problem Description
It was reported that the during investigation of product at the distributorship, the packaging was damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC XR FP TYPE1 PPS
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11345959
• Report Number: 0001825034-2021-00513
• Device Sequence Number: 4997605
• Product Code: OQG
• UDI-Device Identifier: 00880304516885
• UDI-Public: (01)00880304516885(17)280205(10)6219048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 51-102050
• Device Lot Number: 6219048
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1