MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 13.0; PROSTHETIC, HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the inner sterile pouch was not vacuum sealed.Surgeon thought it should have been and requested a new implant.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.The following sections were updated/corrected updated: g3; h2; h3; h6 visual evaluation of the returned product identified that the outer carton was not returned and the outer sterile packaging was open.The inner pouch has multiple crease marks but no hole was visible and there is air inside.The complaint has been confirmed by visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 product was likely conforming when it left zimmer biomet control.Corrective action has been initiated to further investigate the definitive root cause of the lack of vacuum, and confirmed breaches in the packaging are present which have resulted in the pouch losing its vacuum.The breaches in the packaging are likely to have occurred as a result of the porous coating surface rubbing against the pouch during the transit process.The root cause of the issue is transit damage.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 available at the time of this report.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 13.0
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11584632
• MDR Text Key: 245937520
• Report Number: 0001825034-2021-00907
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304513495
• UDI-Public: (01)00880304513495(17)291031(10)6663872
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: 51-107130
• Device Lot Number: 6663872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1