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

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Fatigue (1849); Pain (1994); Burning Sensation (2146); Dizziness (2194); Osteolysis (2377); Reaction (2414); Irritability (2421); Shaking/Tremors (2515); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical product(s): item# unknown/ unknown cup/ lot # unknown; item# unknown / unknown taper/ lot # unknown; item# unknown/ unknown head / lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00924, 0001825034 -2020 -00921, 0001825034 -2020 - 00944.

Event Description

It was reported patient underwent right hip surgery approximately 11 years ago patient has been indicated for a revision surgery due to pain, burning sensation, tenderness and elevated metal ion levels.Further, the patient is noted to have a metal allergy including cobalt.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.

Event Description

It was reported patient underwent right hip revision surgery approximately 10 years post implantation due to pain, burning sensation, tenderness and elevated metal ion levels.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause is unable to be determined as the necessary information to adequately investigate the reported event was not provided 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: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9769349
• MDR Text Key: 181479209
• Report Number: 0001825034-2020-00948
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/18/2020; 04/17/2020
• Supplement Dates FDA Received: 03/13/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention