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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Swelling (2091); Reaction (2414)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown head lot #: unknown; item #: unknown, unknown liner lot #: unknown; item #: unknown, unknown cup lot #: unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right total hip arthroplasty on and unknown date and was revised due to unknown reasons six years later with a zimmer device.Patient underwent additional revision procedure five and a half years post revision due to fractured stem, swelling and periprosthetic fracture.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Initial operative notes were not provided.The patient was revised due to infection and periprosthetic fracture.An unknown zmr stem was implanted.An office visit approximately 10 years later identified metallosis and fatigue fracture.An imaging report identified hardware failure, periprosthetic fracture with displaced fracture fragments with right thigh and hip soft tissue swelling.Operative notes were not provided for the most recent revision.Xrays were provided and reviewed by a healthcare professional.Bone quality was noted as poor.The femur classification is type 4.The primary stem removal method was unable to be determined however it was noted to be through a type of osteotomy.The stem version was noted as neutral and the position in the canal was unable to be determined.The quality of the proximal support and size of the proximal body relative to femur were unable to be determined.The shape of the proximal body relative to the femur was adequate.No strut allografts/adjunctive fixation was used to enhance proximal support.Evidence of osteolysis was unable to be determined.Good distal fixation was unable to be determined.Other factors that could have led to the fracture.A definitive root cause cannot 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.

Event Description

No further event information is 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: 11301948
• MDR Text Key: 230988850
• Report Number: 0001822565-2021-00348
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 97