MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 16X117MM 117MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: source: (b)(6).Multiple reports were submitted along with this report: 0001825034-2021-01795, 0001825034-2021-01796, 0001825034-2021-01797, 0001825034-2021-01798, 0001825034-2021-01799.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.

Event Description

It was reported that the sterile package was damaged.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, h1, h2, h3, h4, h6, h10 visual evaluation of the returned products identified that the outer sterile cavities have been damaged.Sterility has not been compromised on any of the products complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.A corrective action has been previously raised to implement improved packaging changes that were determined.These packaging changes will reduce the number of transit-related packaging damage events.A corrective action was raised to assess the risk.It was determined that no further corrective actions are necessary at this time.Upon investigation, it has been determined that the product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided 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 XR MP T1 PPS 16X117MM 117MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12010539
• MDR Text Key: 256545688
• Report Number: 0001825034-2021-01794
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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: 51-145160
• Device Lot Number: 6147984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1