MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 17.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that during inspection of stock, the sterile package was found damaged.No additional information is available.

Manufacturer Narrative

(b)(4).Report source : foreign: country: japan.Customer has 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: 0001825034-2023-00262, 0001825034-2023-00263, 0001825034-2023-00264, 0001825034-2023-00268, 0001825034-2023-00269, 0001825034-2023-00271.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility had not been compromised.The reported event was confirmed.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event was not related to a combination of products; therefore, a compatibility review was not applicable.The condition of the device when it left zimmer biomet was 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information is available at the time of this report.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 17.0
• 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: 16352600
• MDR Text Key: 309309861
• Report Number: 0001825034-2023-00260
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110400
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 51-107170
• Device Lot Number: 3387034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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