MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 8.0; PROSTHESIS HIP

Model Number N/A

Device Problems Flaked (1246); Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a initial hip procedure, it was noted the surgeon broached to 8 stem.When he went to implant the stem, it sat very proud; he only tapped it 2 or 3 times.He pulled it out to broach it again and noticed some pps seemed to have come off on the medial crack and left coating in the femur.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual examination of the attached pictures do not show any signs of the pps coating delaminating.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 FP TYPE1 PPS HO 8.0
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8726830
• MDR Text Key: 148949130
• Report Number: 0001825034-2019-02669
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 51-101080
• Device Lot Number: 6384852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other