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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930); Blood Loss (2597)

Event Date 04/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products - selex/magnum mod hd 40mm +6, catalog #: s661140, lot #: 094740; e-poly 40mm +3 maxrom lnr sz24, catalog #: ep-108424, lot #: 301420; 3/8-24 apical hole plug 1/cup, catalog #: 123741, lot #: 792980; regen/rnglc+ ltd, catalog #: pt-116058, lot #: 768050; unknown cement, catalog #: unknown, lot #: unknown; ti low profile screw, catalog #: 103533, lot #: 683410.Multiple mdr reports were filed for this event, please see associated reports: head: 0001825034-2019-02215.Liner: 0001825034-2019-02216.Plug: 0001825034-2019-02217.Cup: 0001825034-2019-02218.Screw: 0001825034-2019-02222.

Event Description

It was reported that a patient underwent right total hip arthroplasty and subsequently the patient suffered chronic infection and multiple falls.The last fall caused a periprosthetic fracture resulting in a revision procedure approximately seven years after initial implantation.Operative reports indicate that the patient had persistent wound drainage and difficulty healing the incision.During the revision procedure, the surgeon noted the patient had adipose tissue eight inches deep between the skin and the it band.The surgeon had difficulty removing the stem due to subsidence and bone overgrowth.The stem was grossly loose despite bone overgrowth.Operative reports further indicate that the revision procedure took seven hours to complete with significant blood loss requiring replacement blood product.All products were removed and replaced with competitor product utilizing palacos cement.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Patient was diagnosed with chronic hip infection.During revision surgery it was noted that the stem was loose despite bone overgrowth.Review of the device history record identified no related deviations or anomalies during manufacturing.Root cause was unable to 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.

• 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: 8624600
• MDR Text Key: 145534942
• Report Number: 0001825034-2019-02219
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 139