MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 10X105MM; PROSTHETIC, 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 01/15/2021

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 foreign matter adhered to the white cushioning material when the sterilized packaging of this product was opened.However, this device was used.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The event reports that an unknown type of foreign debris was identified inside the sterile packaging.This was identified during surgery but no further information has been provided (no adverse-event has been reported).The same implant was used to complete the surgery.Product has not been returned and photographs have not been provided, therefore, the reported event is not confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet, and the root cause of the reported event cannot be determined as product has not been returned, and photographs have not been provided.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.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 only the outer packaging and thick foam insert were returned.Visual evaluation of the returned packaging found a small unidentified fiber on the insert.A small amount of roughening was present on the back of the insert but no foreign debris was observed.The front of the insert is also punctured with discoloration within the hole created in the insert.This complaint has been confirmed.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.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 10X105MM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11378569
• MDR Text Key: 233568754
• Report Number: 0001825034-2021-00573
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517295
• UDI-Public: (01)00880304517295
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2021

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: 51-145100
• Device Lot Number: 6737294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 06/24/2021
• Supplement Dates FDA Received: 04/08/2021; 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1