MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 14X148MM 8MM T1; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 51-145150 tprlc, xr mp t1 pps 15x115mm 115mm t1, lot#: 6100418.Catalog#: 51-107130 tprlc, 133 mp type1 pps ho 13.0 m t1, lot#: 3466844.Catalog#: 51-106140 tprlc, 133 mp type1 pps so 14.0 1, lot#: 3899136.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05788, 0001825034-2019-05790, 0001825034-2019-05791.

Event Description

It was reported that upon incoming inspection the inner sterile packaging was damaged.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.D4: udi#: (b)(4).The event is confirmed with product received.Evaluation of the returned product confirmed the sterile packaging (pouch/ blister and pouch) is damaged.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event it likely to be damage during transit.A corrective action was opened to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this action, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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.

• Brand Name: TPRLC 133 T1 PPS HO 14X148MM 8MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9532796
• MDR Text Key: 204209831
• Report Number: 0001825034-2019-05789
• Device Sequence Number: 1
• Product Code: KWA
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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 Model Number: N/A
• Device Catalogue Number: 51-104140
• Device Lot Number: 6127286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1