MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMP 2.0 MM SS CABLE/SLEEVE COMBO; CERCLAGE, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-0871, 32mm cocr biomet fem hd -3 nk, 1806301; 22-300919, arcos 19x190mm spl tpr dist ha, 729090; 22-301300, arcos con sz a std 50mm ha, 633150; ep-105833, epoly rlc 32mm 10deg sz23, 220060; unknown hip shell; unknown cable attachment.(b)(6).The complaint cannot be confirmed as the follow op notes were not provided.X-rays were reviewed; overall fit and alignment of the implants is appropriate.Osteopenia is present on all images.X-ray demonstrates lucency along the proximal femoral component which can suggest early loosening.Oblique fracture of the proximal femoral diaphysis laterally is also seen on this image which could mean the periprosthetic fracture sustained causing the revision never healed.This, however, is unconfirmed.The device history records reviewed and identified no anomalies or deviations.Root cause could not be determined with information available.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01363; 0001825034 - 2018 - 01364; 0001825034 - 2018 - 01366; 0001825034 - 2018 - 01367; 0001825034 - 2018 - 08732.

Event Description

It was reported in a clinical study that a patient underwent right hip revision surgery following a periprosthetic fracture, and subsequently, the patient reported moderate pain and inability to perform usual activities at a follow up visit approximately two years post operatively.No additional information is available.

• Brand Name: BMP 2.0 MM SS CABLE/SLEEVE COMBO
• Type of Device: CERCLAGE, FIXATION
• 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: 7854056
• MDR Text Key: 119488427
• Report Number: 0001825034-2018-08730
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK982545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 350806
• Device Lot Number: 300410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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): Other
• Patient Age: 81 YR
• Patient Weight: 62