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

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Naturally Worn (2988)

Patient Problems Ossification (1428); Erosion (1750); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 07/06/2021

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 has been completed, a follow-up mdr will be submitted concomitant products: part # unknown / unknown shell/ lot # unknown.Part #unknown / unknown stem/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01012.0001825034 -2021 -01013.

Event Description

It was reported that patient underwent initial left total hip arthroplasty approximately 16 years ago.Subsequently, the patient has reported mild unknown symptoms and elevated chromium levels.However, no revision procedure has been reported to date.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.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: summarized by hcp findings: recent metal ion levels cobalt 2.1 (normal <4.0), chromium 2.1 (normal <0.6) the left hip only has minor symptoms at this time root cause could not 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.

Event Description

It was reported that patient underwent a left hip revision surgery 15 years post implantation due to metal related pathology.Pain and instability was reported.Surgeon noted surgery was extensive due to muscle damage, osteolysis, bone loss/erosion, ho and scar tissue.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 investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues recent ion levels were high but lowered after the revision, extensive scar tissue, bone loss, muscle detachment, instability, wear debris, tumor, osteolysis, and altr as reported.Pain increase with weight-bearing.Corrosion on the head and taper, ho around the greater trochanter.No further complications were noted.The additional information does not change the outcome of the previous investigation.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 h6: remove type of investigation code 4114: device not returned review of the returned head noted the outside diameter is scuffed.The additional information does not change the outcome of the previous 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.

• Brand Name: UNKNOWN HEAD
• 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: 11636255
• MDR Text Key: 244491539
• Report Number: 0001825034-2021-01011
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 104 KG