MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM PRIM FEM ST 13MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Blurred Vision (2137); Burning Sensation (2146); Sore Throat (2396); Numbness (2415); Tooth Fracture (2428); Balance Problems (4401); Metal Related Pathology (4530); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 was 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 01976.

Event Description

It was reported the patient underwent a left hip revision approximately 6 years post implantation due to pain, metallosis, and elevated ion levels.Corrosion of the trunion was also noted.It was also reported before the revision, patient suffered from hearing loss, pain in the lower back, burning sensation, pain in the ears, mouth issues, numbness and tiredness.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: cat#00-8018-032-02 lot#62847098 head, cat#00-6305-050-32 lot#62842925 liner, lot#62779497 shell, lot#62825599 screw.

Event Description

It was reported the patient underwent a left hip procedure.Subsequently, the patient was revised due to metallosis, and elevated ion levels, a gradual onset of neurological symptoms, with left hip, buttock and lower back pain, radiating down the extremity, subsequently developed a mylar (butterfly) rash, burning throat and ears, blurry vision, hearing and memory impairment, tooth breakdown, mouth sores with residual pain, numbness in lips, hands, swollen fingers with impaired grasp, loss of balance, fatigue and dysphoria.A blood test for metal ions was conducted through the clinic in results confirmed toxic levels of cobalt and chromium, and elevated levels of titanium.An emergency revision surgery was recommended.Due to covid precautions the revision was delayed.Operative findings indicated clear evidence of trunnionosis with blackening of the trunnion.Subsequent pathology reports describe prosthetic wear debris reaction including granulomatous response to metal particles.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, g3, h2, h3, h4, h6.H6: proposed component code: mechanical (g04)- stem.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Additional information does not change the root cause of the initial investigation.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: TM PRIM FEM ST 13MM
• 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: 12196046
• MDR Text Key: 262493877
• Report Number: 0001822565-2021-01977
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2023

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: 00786401300
• Device Lot Number: 62833317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 11/27/2022; 12/29/2022
• Supplement Dates FDA Received: 12/12/2022; 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2014
• 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: HIP-HEAD-UNKNOWN-; SEE H10 NARRATIVE; HIP-HEAD-UNKNOWN-
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female