MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 15X150MM; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(6).

Event Description

The surgeon was performing a primary taperloc complete operation, after rasping the intramedullary canal and trailing, he attempted to implant the taperloc stem.The stem would not seat properly and sat up too high.A second taperloc stem of the same size was successfully implanted.The surgeon believes the stem that would not seat had a porous coating that was too thick.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Udi:(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual inspection of the stem identified marking on the taper and visible damage to the extraction hole likely caused during attempt to extract the stem from the canal.A small amount of discoloration and foreign debris were observed in the porous coating.The overall length was measured using digital calipers and is within print specification.The gap gauge check was performed and placed adjacent to the extraction face as required and is found to be within specification.The graticule check was performed using graticule number and the porous coat area sits between the tolerance bands when lined up with the stem profile as per specification.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 15X150MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8249234
• MDR Text Key: 133110567
• Report Number: 0001825034-2019-00112
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-104150
• Device Lot Number: 6408255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 80