MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 20X160MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Flaked (1246); Peeled/Delaminated (1454)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.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 a hip procedure, the stem was impacted then removed for a bigger size.Upon removing it was found that the porous coating flaked off and was stuck to the bone.The wound was irrigated to remove the coating with no harm or injury to the patient.The surgery was completed with a second implant successfully.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.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause 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.

Event Description

No additional event information to report at this time.

• Brand Name: TPRLC 133 T1 PPS HO 20X160MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11664933
• MDR Text Key: 250324184
• Report Number: 0001825034-2021-01072
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304499270
• UDI-Public: (01)00880304499270(17)301118(10)6899256
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 51-104200
• Device Lot Number: 6899256
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1