MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM MAXROM LNR SZ25; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Renal Failure (2041)

Event Date 08/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 06654; 0001825034 - 2018 - 06655; 0001825034 - 2018 - 06656.Concomitant medical products: 15-103207 femoral stem, lot unk; 650-1058, femoral head, ceramic, lot unk; 11-104060 m/h radial shell, lot unk.Reported event was confirmed due to review of provided medical records and/or patient x-rays.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.Root cause was unable to 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.Not returned to manufacturer.

Event Description

It was reported the patient had a two-stage revision to address infection with positive group g strep with renal failure complications.The devices were reimplanted.No further information has been made available.

Manufacturer Narrative

Concomitant medical products: 15-103207 femoral stem, lot 605500, 650-1058 cer bioloxd option hd 40mm, lot 714980, 11-104060 m/h radial shell, lot 318980.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.

Manufacturer Narrative

Reported event was confirmed by review of medical records received.The patient presented with hip pain, acute severe cellulitis treated with antibiotics.Aspiration of hip joint revealed greater than 200,000 white blood cells with a significant shift and positive for group g strep, all indicative of infection.Upon incising the fascia, purulence was noted and had caused necrosis of the anterior repair with significant soft tissue loss.All components were removed, wound irrigated.Two cables were used to repair the bone from osteotomy.New components implanted with spacer.Hemovac drain placed.No further complications noted.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: E-POLY 40MM MAXROM LNR SZ25
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7761473
• MDR Text Key: 116375855
• Report Number: 0001825034-2018-06657
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK070364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

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 Expiration Date: 10/28/2012
• Device Model Number: N/A
• Device Catalogue Number: EP-107825
• Device Lot Number: 568720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 09/20/2018
• Supplement Dates FDA Received: 08/08/2018; 10/18/2018
• 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: 39 YR
• Patient Weight: 107