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

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: ref 00700006220 lot 63959491 tm shell; ref 00710506240 lot 64210793 longevity liner; ref 00625006520 lot 63010444 screw; ref 00625006530 lot j6858532 screw; ref 00625006540 lot 64825901 screw; ref 00625006540 lot j6710215 screw; ref 650-1058 lot 3043515 biolox head; ref 650-1066 lot 3050922 biolox sleeve; ref 00710506240 lot 64210793 longevity liner; ref 51-104150 lot 6948764 taperloc stem; ref 00223200418 lot 64952399 cerclage wire.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02935.

Event Description

It was reported the patient underwent left tha due to femoral neck fracture.Subsequently, patient was revised two days later due to an iatrogenic acetabular fracture.The patient underwent a second revision approximately 4 months later due to pain and instability with placement of a custom cage and constrained liner.During the revision, significant scarring was noted which prompted the removal of the femoral component.The acetabular component was found well fixed and ingrown.The cemented liner was removed as well as the cup.Backing out the screws was not possible, so the surgeon cut them with a bur so that the custom cage could be placed.Due to intraoperative complications, only the custom cage, liner, and screws were placed.The wound was closed without femoral components in place, and the patient was transferred to the critical care unit.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: patient was revised for acetabular cup failure with significant scarring noted; therefore, the femoral component was revised with no complications.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot 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

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

• Brand Name: TPRLC 133 T1 PPS HO 15X150MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12688892
• MDR Text Key: 278117674
• Report Number: 0001825034-2021-02934
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304489776
• UDI-Public: (01)00880304489776(17)310122(10)6948764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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: 51-104150
• Device Lot Number: 6948764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG