MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 BM HO 11.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problem Hip Fracture (2349)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 650-1158, lot number: 2018112262, brand name: delta ceramic head; catalog number: ep-200150, lot number: 2478400, brand name: articular hip bearing unknown cup.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to subsidence of stem and fracture of the calcar approximately three (3) months post implantation.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  udi : (b)(4).X-rays were provided and sent for further assessment.The final report states that right hip arthroplasty components are anatomically aligned without subluxation or dislocation.There appears to be a slightly displaced fracture of the calcar.The femoral component appears subsided with elevation of the greater trochanter in relation to the acetabulum.There is a cleft at the medial base of the greater trochanter, chronic in appearance.Reported event was confirmed by review of x-rays provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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

It was reported that the patient was revised due to subsidence of stem and fracture of the calcar approximately two (2) months post implantation.Additional information on the reported event is unavailable at this time.

• Brand Name: TPRLC 133 MP TYPE1 BM HO 11.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8722829
• MDR Text Key: 148790936
• Report Number: 0001825034-2019-02706
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• 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: 08/28/2019

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: 51-117110
• Device Lot Number: 6199636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention