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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: country: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02342, 0001825034-2020-02344, 0001825034-2020-02345, 0001825034-2020-02346, 0001825034-2020-02347, 0001825034-2020-02348.

Event Description

It was reported upon inspection at the incoming warehouse, there was debris in the sterile package.No patient involvement.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, d10, g4, h2, h3, h4, h6 complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned products confirmed foreign debris is present inside the sterile packaging and the sterile packaging remains sealed.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the devices when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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 FP TYPE1 PPS HO 6.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10201125
• MDR Text Key: 198682303
• Report Number: 0001825034-2020-02343
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304499072
• UDI-Public: (01)00880304499072(17)300305(10)6751927
• Combination Product (y/n): N
• PMA/PMN Number: K103755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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: 51-101060
• Device Lot Number: 6751927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1