MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 -014 -01100.The reported event could not be confirmed as the product was not returned, no visual and dimensional evaluations could not be performed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Unable to perform a complaint history review based on the provided information.Root cause was unable to be determined as the information provided was limited.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.Not returned to manufacturer.

Event Description

It was reported the patient had pain, difficulty ambulating, feeling of implant migration, and numbness.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 00625006525 ¿ bone screw ¿ 60470093.00625006550 ¿ bone screw ¿ 60436495.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 patient is reporting severe pain, instability, decrease in activities in daily life, and a fall causing device to push on sciatic nerve resulting in leg numbness.There is reported metallosis causing psoriasis and surgeon notes defective based off x-rays, the head is not seated properly.The patient ultimately underwent a right hip revision approximately 14 years post implantation.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

H6: component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the head and stem.Root cause unchanged.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: UNKNOWN STEM
• 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: 7957465
• MDR Text Key: 123428486
• Report Number: 0001822565-2018-05391
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 00620205420 CUP LOT 60560945; 00631005028 LINER LOT 60525995; SEE H10; UNKNOWN HEAD; 00620205420 CUP LOT 60560945; 00631005028 LINER LOT 60525995; UNKNOWN HEAD
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG