MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC TPRLC 133 FP TYPE1 BM HO 12.0; 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 03/24/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: country: united kingdom.Customer has indicated that the product was discarded and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial surgery, the internal plastic housing for the implant was noted to be broken within the package.The box or external packaging was intact; however, it was noticed the hard plastic packaging had a crack and a hole in it while opening.It was reported that the implant sterility was compromised, and there was a 10-minute delay while they obtained a replacement implant of the same size in the middle of the surgery.There was no reported adverse patient impact.No additional information was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.-visual evaluation of the provided photo identified damage to the sterile packaging (blister).Sterility has been compromised.-review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.-medical records were not provided.-the condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.-the reported event has been confirmed by evaluation of the provided photos.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 information is available at the time of this report.

• Brand Name: TAPERLOC TPRLC 133 FP TYPE1 BM HO 12.0
• 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: 19079989
• MDR Text Key: 340400284
• Report Number: 0001825034-2024-00991
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304499539
• UDI-Public: (01)00880304499539(17)331205(10)7671149
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103755
• 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: 04/30/2024

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: 51-111120
• Device Lot Number: 7671149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1