MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 MAXROM LNR SZ23; PROTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that the patient had an initial left total hip arthroplasty.Approximately six years post-op, the patient had an acute onset of pain and limited mobility.Radiographic imaging displayed acetabular dissociation.Subsequently, the patient underwent a revision, where evidence of metallosis was noted between the femoral head articulating against the metal acetabular shell, and the poly liner was found broken in five pieces with wear.All components, except for the stem, were revised.There were no reported intra-operative complications.No additional information available.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01015, 0001825034-2023-01018, 0001825034-2023-01019.D10: cat# 15-103203 lot# 565060 taperloc microp lat fmrl 9.0mm, cat# 12-104152 lot# 447270 m/h radial 3-hole shell 52mm, cat# 650-1057 lot# 130640 cer bioloxd option hd 36mm, cat# 103530 lot# 939650 ti low profile screw 6.5x15mm, cat# 103531 lot# 921530 ti low profile screw 6.5x20mm.

Event Description

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

Manufacturer Narrative

The following section was corrected: a1.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a healthcare professional.A review of the available records identified findings of the reported issue.Failed left total hip arthroplasty with liner fracture/disassociation.Acute onset of pain, disassociation with well-fixed acetabular component.Evidence of metallosis between the head and shell.Poly liner broken into 5 pieces and demonstrates wear.The reported issue was confirmed; however, 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.

• Brand Name: E-POLY 36MM +3 MAXROM LNR SZ23
• Type of Device: PROTHESIS, 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: 16910578
• MDR Text Key: 314986228
• Report Number: 0001825034-2023-01016
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 279030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female