MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC XR FP TYPE1 PPS; PROSTHESIS, HIP

Catalog Number 51-102080

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item# 51-101080/ tprlc 133 fp type1 pps ho /lot # 3751410, item# 51-104130/ tprlc 133 t1 pps ho/ lot # 2711291, item# 51-102070/tprlc xr fp type1 pps/ lot # 3429122, item# 51-107100/ tprlc 133 mp type1 pps ho/ lot # 3786480, item# 51-105090/ tprlc xr t1 pps/ lot # 3406165.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02851, 0001825034-2020-02852, 0001825034-2020-02854, 0001825034-2020-02856, 0001825034-2020-02857.

Event Description

It was reported that during circulation of product in warehouse, debris was found in the sterile packaging.There was no patient involvement.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.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Additional review found debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event is the operator not following the work instructions provided.The white foam debris is likely due to transit damage.The event is being further reviewed through the capa process.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: TAPERLOC XR FP TYPE1 PPS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10304995
• MDR Text Key: 199892428
• Report Number: 0001825034-2020-02855
• Device Sequence Number: 1
• Product Code: LPH
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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 Catalogue Number: 51-102080
• Device Lot Number: 3751538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10