MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR FP TYPE1 PPS 4X128MM; PROTHESIS, HIP

Model Number N/A

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

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported circulated items in stock were inspected and the sterile package was damaged.There was no patient involvement.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: 51-100050 tprlc 133 fp type1 pps so 5.0 6747545, 51-104150 tprlc 133 t1 pps ho 15x150mm 6133620.Customer had indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2022 -02767, 0001825034 -2022 -02769.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 -02767 - 1, 0001825034 - 2022 -02769 - 1.Lot 6826058 -visual evaluation of the returned product/provided photo(s) identified damage to the sterile packaging (blister).Sterility has not been compromised.Reported event has been confirmed review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Lots 6757545; 6826058 -review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported item and lot combination(s).The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: TPRLC XR FP TYPE1 PPS 4X128MM
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15958352
• MDR Text Key: 305697804
• Report Number: 0001825034-2022-02768
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304516878
• UDI-Public: (01)00880304516878(17)300811(10)6826058
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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 Model Number: N/A
• Device Catalogue Number: 51-102040
• Device Lot Number: 6826058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1