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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Irritation (1941); Thrombosis (2100); Joint Dislocation (2374)

Event Type  Injury  

Event Description

Information was received based on a review of a manuscript titled, "short-term outcomes of the second generation uncemented stem in total hip arthroplasty¿ which reviewed the short-term outcomes of echo bi-metric comparing it to its bi-metric predecessor.This manuscript reports the short-term outcomes of echo bi-metric stem and how renewed features affect the outcomes including harris hip scores and radiographic analysis.From 1986 to 2005, sixteen hundred and six (1606) total hip arthroplasties were performed using an uncemented bi-metric femoral stem.From 2005 to 2014, thirteen hundred and seventy-four (1374) total hip arthroplasties were performed using the echo bi-metric fpp stem and three hundred and sixty-six (366) total hip arthroplasties were performed with the echo bi-metric rpp stem.Of these, fourteen hundred and ninety-seven (1497) bi-metric stems in 1280 patients, 1277 echo fpp in 1104 patients and 366 echo rpp in 317 patients were included in this manuscript.Postoperatively, there were three (3) dislocations, three (3) infections, four (4) irritation and drainages and one (1) dvt (deep vein thrombosis) for echo fpp.There was one (1) irrigation and drainage for echo rpp.There were thirty-nine (39) dislocations, three (3) infections, one (1) irrigation and drainage and two (2) dvts for bi-metric.Regression analysis revealed that posterior approach had 2.2 times odds of dislocation compared to anterior approach in the study.It also revealed that the femoral head of size 28mm and under had 9.09 times odds of dislocation compared to that of size 32 mm, and 22.73 times odds of dislocation compared to that of size 36 and over.In conclusion, the second generation uncemented stem; echo fpp and echo rpp demonstrated excellent outcomes with 100% survivorship and less dislocation.There was no statistical difference in survivorship or harris hip scores between them.The echo fpp and echo rpp have a good start and it is expected to have excellent outcomes in the future research and analysis.

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 manuscript.The following sections could not be completed with the limited information provided.Date of event - unknown; catalog number, lot number and expiration date - unknown; date implanted - unknown; dates explanted - unknown ; initial reporter -the article was written by sueyoshi, t., et al; manuscript: joint replacement surgeons of indiana research foundation.Manufacture date ¿ unknown.It is likely that these complications 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 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

This report addresses: thirty-nine (39) hip dislocations post-op primary tha with bi-metric device.Additional information revealed that the bi-metric group were mostly performed through a posterior approach and used smaller head size (28 cm or below).There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN BI-METRIC 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: 4603510
• MDR Text Key: 5469671
• Report Number: 0001825034-2015-00993
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative,company representative
• 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?: Yes
• 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: 02/17/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: 02/17/2015
• 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): Required Intervention