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

Model Number N/A

Device Problems Device Slipped (1584); Unstable (1667); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bone Fracture(s) (1870); Pain (1994); Thrombosis (2100); Post Operative Wound Infection (2446)

Event Type  Death  

Event Description

O'donnell, t.Et al.Volume 468, number 11, november 2010.Clin orthop relat res (2010) 468:3094¿3102.Information was received based on review of a journal article entitled, "the repicci ii unicondylar knee arthroplasty 9-year survivorship and function." (b)(6) using minimally invasive surgery (mis) has the theoretical advantage of less bone resection and quicker rehabilitation.The aims of the study were to determine (1) the length of stay and complications associated with a short-stay mis protocol; (2) whether mis techniques allow for accurate positioning of the implant and alignment of the limb; (3) the change in functional scores; (4) the revision rate, reasons for revision, and survival of this implant.This study prospectively followed 100 patients who had 114 (b)(6).The average age of the patients at the time of surgery was 67 years (range, 48¿87 years).At the time of follow-up, seven patients had died, all of whom had unilateral procedures, leaving a total of 93 patients (107 knees).None of the patients who died had revision of their prosthesis, nor were any on a waiting list for revision surgery.No patient was lost to follow-up.The average body mass index (bmi) was 28.9 (range, 19.9¿47.7).There were 52 men and 41 women, with 61 right and 46 left (b)(6) performed.Minimum follow-up was 5.2 years (mean, 7.4 years; range, 5.2¿9 years).The repicci ii1 (biomet, inc, warsaw, in, usa) cobalt-chromium femur/all-polyethylene tibia fixed bearing prosthesis was implanted in all cases.Patients were seen again for follow-ups at 6 months and 1 year postoperatively, at which stage repeat radiographs were performed.Eight patients had perioperative complications: 1 superficial wound infection, 1 hemarthrosis, 2 deep venous thrombosis, 3 pes anserinus pain and 1 excessive pain.22 patients were revised for one of four reasons: progression of disease to lateral compartment, progression of disease to lateral and patellofemoral compartments, subsidence of tibial tray attributable to stress fracture, malalignment, or aseptic loosening.All 22 patients will be listed in separate complaint numbers.(b)(6) using a minimal resection mis technique is a technically demanding procedure.Our results show the survivorship and rate of revision are not as good as those reported for other (b)(6) techniques using fixed mobile bearing prostheses.However, patients had reasonable functional scores, and the (b)(6) we performed can be revised to a tka without the need for stems or wedges.It is possible to consistently implant the prosthesis in an anatomic position.

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 o'donnell, t.Et al.In volume 468, number 11, november 2010.Clin orthop relat res (2010) 468:3094¿3102.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

This follow-up report is being submitted to relay additional information: the following sections were updated: outcomes attributed to adverse event, added additional information, catalog and lot number, email address, patient and device codes, type of reportable event, method, results, and conclusion codes, manufacturer narrative.(b)(6).The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item 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.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

A review of the article identified seven (7) unknown patients that underwent an unilateral procedure, that expired for unknown reason on an unknown date there has been no further information provided.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• 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: 4902117
• MDR Text Key: 6534835
• Report Number: 0001825034-2015-02963
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• 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
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• 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): Death; Hospitalization; Required Intervention