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

Model Number N/A

Device Problems Disassembly (1168); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Complaint, Ill-Defined (2331); No Information (3190)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "low infection rate after tumor hip arthroplasty for metastatic bone disease in a cohort treated with extended antibiotic prophylaxis." compared to conventional hip arthroplasty, endoprosthetic reconstruction after tumor resection is associated with a substantially increased risk of periprosthetic joint infection (pji), with reported rates of around 10% in a recent systematic review.This is a retrospective review of all adult patients who underwent endoprosthetic reconstruction of the proximal femur after tumor resection for metastatic bone disease during a 4-year period from 2010 to 2013.The overall infection rate was 3.6% (4/111 implants), infection free survival was 96% at 2 years, and the risk of amputation associated with infection was 25% (1/4 patients).Identified were 105 patients (mean age = 65 (range 16¿92) years, m/f = 45/60), who had received a total of 111 hip implants.The primary indication for surgery was de facto or impending pathological fracture of the proximal femur due to metastatic bone disease.Eleven of the identified patients received a biomet bi-metric femoral stem.One patient identified received a biomet ranawat cup.All other patients identified received competitor components.The journal article indicated the following adverse events; however, it is not known which (if any) of these patients received biomet components: ten (10) dislocations, four (4) periprosthetic joint infections resulting in irrigation and debridement and revision of components, one (1) mechanical complication, one (1) local recurrence, in conclusion, preemptive eradication of bacterial contamination after endoprosthetic reconstruction subsequent to malignant bone tumor resection by means of extended postoperative antibiotic prophylaxis may reduce the risk of pji in this high-risk patient population.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Date of event - unknown.Expiration date - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by werner h hettwer in advances in orthopedics (2015), article id 428986, 6 pages.Manufacture date ¿ unknown.It is likely that these complications and revisions have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

Manufacturer Narrative

(b)(4).This supplemental report is being submitted to address only one event of the article.The following fields have been updated with additional/ updated information.Event description, patient/ device codes, evaluation codes, manufacturer narrative.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.This report is being submitted late as it has been identified in remediation.

Event Description

Information was received based on review of a journal article entitled, "low infection rate after tumor hip arthroplasty for metastatic bone disease in a cohort treated with extended antibiotic prophylaxis." compared to conventional hip arthroplasty, endoprosthetic reconstruction after tumor resection is associated with a substantially increased risk of periprosthetic joint infection (pji), with reported rates of around 10% in a recent systematic review.This patient experiences a revision due to alleged dislocations on an unknown date.There has no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN, HIP
• Type of Device: UNKNOWN, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4594619
• MDR Text Key: 5454130
• Report Number: 0001825034-2015-00973
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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
• Device Catalogue Number: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: 02/16/2015
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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