MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN, HIP; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Device Inoperable (1663); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Hematoma (1884); Unspecified Infection (1930); Myocardial Infarction (1969); Swelling (2091); Joint Disorder (2373); Joint Dislocation (2374); Spinal Cord Injury (2432); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Death  

Event Description

Information was received based on review of a journal article titled, "outcomes of modified harrington reconstructions for nonprimary periacetabular tumors: an effective and inexpensive technique".The purpose of the study was to: 1) study the durability of a cement-screw rebar technique and 2) study the risk factors for failure.3) compare the results to other reconstruction options using a gentamicin-impregnated bone cement, high-wall all-polyethylene cups, and long-stem biometric implants all manufactured at biomet.This study consisted of fifty-two (52) reconstructions performed on 50 patients.Mean age was 57 years old.Twenty-four (24) lesions were harrington class ii and 28 were harrington class iii.9 patients had massive ischial tumor burden.Thirteen (13) reconstructions were supplemented with antegrade steinman pins for anterior column compromise.Mean patient follow-up was 17.7 months.The journal article reports thirty-four (34) of fifty (50) patients died of disease with a mean survival of 18.9 months.Five-year overall survival was 21% and 10-year survival was 12%.Sixteen (16) patients were alive with disease with a mean follow-up of 24 months.The journal article reports five (5) of fifty-two (52) prostheses failed due to the following reasons: three (3) constructions failed as a result of acetabular loosening resulting from tumor progression one (1) due to aseptic loosening, one (1) dislocation.Of the four reconstructions that loosened, two were in patients with harrington class ii lesions and two occurred in patients with harrington class iii lesions.Two were revised and two were in patients deemed medically unfit for further surgery.Both of the patients who underwent revisions developed deep infections and were treated with girdlestone procedures within 6 months for symptomatic, aseptic loosening.The implant that dislocated underwent an unsuccessful attempt at closed reduction, and it was not revised.Post-op hematoma occurred in a patient with metastatic renal cell carcinoma who did not undergo pre-operative embolization, leading to sciatic nerve palsy that prompted surgical decompression.There were two major medical complications in the immediate postoperative period.One patient died as a result of a postoperative myocardial infarction, and another developed worsening spinal cord compression in the immediate postoperative period.There was one minor complication of a screw fracture in an otherwise stable hip.Two patients did not ambulate after surgery.In conclusion, the screw-cement-rebar all-polyethylene cup technique of acetabular reconstruction is a comparatively successful and inexpensive reconstruction option for treating metastatic disease to the acetabulum.

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 society of surgical oncology 2015, doi: 10.1245/s10434-015-4507-2.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

Zimmer biomet complaint: (b)(4).This report is being submitted late as it has been identified in remediation.This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) and complaint history review was unable to be performed as the part and 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.

Event Description

The referenced journal article reports five (5) of fifty-two (52) prostheses failed.This report addresses one (1) construction which failed as a result of acetabular loosening resulting from tumor progression which occurred in patients with massive preoperative ischial tumor burden at time point 19 months.

• Brand Name: UNKNOWN, HIP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 4765200
• MDR Text Key: 5949552
• Report Number: 0001825034-2015-01968
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,health professional,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• 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: 04/29/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: 04/29/2015
• Supplement Dates FDA Received: 10/26/2017
• 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