MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 BM HO 6.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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.

Event Description

It was reported that the inner sterile package for the implant appeared damaged.There was an increased length of anesthetic time due to waiting for a replacement 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: e1; e2; e3; e4; a2; a3; g3; g4.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional information on the reported event.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information provided by the customer.The dhr was reviewed and no discrepancies were found.The root cause of the reported event is unable to be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was returned, visual evaluation of the product identified that the sterile cavity, and pouch housing the stem has been damaged, and there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Review of the device history records identified no deviations or anomalies during manufacturing.The product was likely conforming when it left zimmer biomet control.The root cause of the reported issue is attributed to 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 additional information on the reported event.

• Brand Name: TPRLC 133 FP TYPE1 BM HO 6.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10507622
• MDR Text Key: 207193237
• Report Number: 0001825034-2020-03471
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304499478
• UDI-Public: (01)00880304499478
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 51-111060
• Device Lot Number: 6356921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 47 YR