MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP T1 PPS SO 5X95MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that during inspection of product in the warehouse, debris was found in the sterile packaging.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photograph identified that there is debris in sterile packaging.Reported event is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The work instruction for the operation where the manufacturing deviation is likely to have occurred (i000132 rev 17) was reviewed and found to be adequate information informing the operator to inspect packaging for foreign material inside the sterile packaging.Device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review (reference (b)(4) and (b)(4)) in order to identify potential adverse trends.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The likely condition of the device when it left zimmer biomet, or the root cause of the reported event cannot be determined.

Event Description

There is no additional information to report.

Manufacturer Narrative

His follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found a foreign fiber in the sterile packaging that is unacceptable to (b)(6).This complaint has been confirmed by evaluation of the returned product.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.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

There is no update to the prior event description provided.

• Brand Name: TPRLC 133 MP T1 PPS SO 5X95MM
• 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: 15600832
• MDR Text Key: 306326897
• Report Number: 0001825034-2022-02296
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304515253
• UDI-Public: (01)00880304515253(17)320114(10)7121714
• 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,Followup
• Report Date: 06/22/2023

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: 51-108050
• Device Lot Number: 7121714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 11/02/2022; 06/22/2023
• Supplement Dates FDA Received: 11/04/2022; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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