MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS SO 16X152MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is not being returned to zimmer biomet for the investigation as the product has been used.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the package of a stem component was found to be not vacuum sealed.It is unknown at this time if there is a hole causing the vacuum to release or if the package was not vacuumed during manufacture.The product was used due to urgency of the surgery, however no harm or injury to the patient has been reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photos identified pouch damage and loss of vacuum seal.No evidence of sterile packaging breaches were found that would explain the loss of the vacuum seal.However as product was not returned, it cannot be determined if sterility has been compromised.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event can be attributed to transit damage, and a packaging design issue.A summary of the investigation was requested and sent to the customer.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 additional event information to report at this time.

• Brand Name: TPRLC 133 T1 PPS SO 16X152MM
• Type of Device: PROSTHESIS, 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: 14548607
• MDR Text Key: 292985099
• Report Number: 0001825034-2022-01312
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304489691
• UDI-Public: (01)00880304489691(17)310219(10)6970129
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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: 51-103160
• Device Lot Number: 6970129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 72 KG