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

Model Number N/A

Device Problems Corroded (1131); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02489, 0001825034-2022-02490, 0001825034-2022-02491.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.

Event Description

It was reported that a patient underwent a left hip revision approximately twelve years post implantation due to pain.During the procedure, metal debris, corrosion to trunnion, scar tissue and adhesions were noted and the head, taper adapter was exchanged, and a bearing placed.Excessive blood loss was also noted at the end of the procedure, but no transfusion was required.It was reported that no further information is available.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Insufficient information provided.Complaint history review cannot be performed without product identification.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues pain, metal debris debrided in posterior external rotator region, mild corrosion on the trunnion, scar tissue from previous surgery.No other complications.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

There is no update to the original complaint description provided.

• Brand Name: UNKNOWN TAPER ADAPTER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15755513
• MDR Text Key: 303275819
• Report Number: 0001825034-2022-02492
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BIMETRIC STEM.; UNK MAGNUM HEAD.; UNK MAGNUM PF CUP.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male