MAUDE Adverse Event Report: ZIMMER TMT PROXILOCK TI HA STEM, 12MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No clinical records, images, or devices were returned for review.The patient¿s medical condition can lead to pain in the joints due to easy bruising and hyperextension.As no additional records have been provided, the diagnosis alone cannot rule out the device as the cause of the pain in this patient and does not account for the additional allegations.A review of the device history records could not be performed as the lot number is unknown.A 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.Concomitant medical products: 01-100-28002, head superpolish 28mm od +0 nl, lot unknown.02-210-00523, trabecular metalâ¿¢ acetabular revision shell, lot unknown.00630504828, liner standard 28 mm i.D.For use with 48 mm o.D.Shell, lot 69078700.

Event Description

It was reported that approximately 17 years post implantation, the patient is experiencing pain.It was also reported that x-rays identified osteolysis.Patient has also had allegations of increased memory issues, incomplete sentences, and speech problems.Attempts have been made and no further information has been provided.

• Brand Name: PROXILOCK TI HA STEM, 12MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 10000185
• MDR Text Key: 189151290
• Report Number: 3005751028-2020-00033
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-220-12361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 04/27/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76