MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL LAT 7.5X135; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02063, 0001825034 - 2022 - 02064.

Event Description

It was reported that patient underwent a right hip revision approximately 13 years post implantation due to pain and lucency found on xray.During the procedure, metallosis, osteolysis, altr, pseudotumor and periprosthetic fracture were noted.All components were removed and replaced with competitor products.Due to extensive bone loss, pseudotumor and metallosis, additional surgery time was required to complete the surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d1; d2; d4; g3; g4; h2; h3; h4; h6 h6: component code mechanical (g04)- stem medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed with no complications noted.A revision occurred as the patient presented with pain, elevated metal ions, and a trochanter fracture.During the revision, a severe local tissue reaction was found consistent with metallosis.Significant osteolysis was also found around the acetabulum and trochanteric region, with bone loss.A pseudotumor was removed and added an hour to the operation time with the significant bone loss.No complications were noted upon completion of the revision, and competitor products were placed.Review of the device history records identified no 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 additional event information to report at this time.

• Brand Name: TAPERLOC POR FMRL LAT 7.5X135
• 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: 15366756
• MDR Text Key: 299354227
• Report Number: 0001825034-2022-02066
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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 Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-103202
• Device Lot Number: 182500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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: UNK NECK
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female