MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOCK-SCR CANCLS 6.5X40MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Unequal Limb Length (4534)

Event Type  Injury  

Event Description

It was reported by the pmi group that a patient underwent right hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product on an unknown day due to leg length discrepancy.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00580, 0001825034 - 2023 - 00581, 0001825034 - 2023 - 00583, 0001825034-2023-00584, 0001825034 - 2023 - 00585, 0001825034 - 2023 - 00586, 0001825034 - 2023 - 00587.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.D10: cat# xl-108525 lot# 832500 arcomxl 40mm +3 hw lnr sz 25, cat# 11-300916 lot# 937720 arcos 16x190mm spl tpr dist, cat# 11-301324 lot# 836460 arcos con sz d std 70mm, cat# 010001036 lot# 6726723 cocr fem hd 40mm type 1 -3mm, cat# 00223200418 lot# 64629062 cable cerclage cable with crimp 1.8 mm dia.635 mm length.It was reported that one of the seven screws fractured.It is unknown which screw has fractured.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the acetabular implant is loose and displaced superiorly as noted.Bone quality is osteopenic.All of the screws appear loose and an inferior screw is fractured.The resulting superior displacement of the arthroplasty would result in a limb length discrepancy.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 information at the time of this report.

• Brand Name: TI LOCK-SCR CANCLS 6.5X40MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16582216
• MDR Text Key: 311666935
• Report Number: 0001825034-2023-00582
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304510890
• UDI-Public: (01)00880304510890(17)270430(10)035500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

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: CP161945
• Device Lot Number: 035500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 07/12/2023
• Supplement Dates FDA Received: 04/19/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2017
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male