MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA TI MOD HEAD ION STD NK PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The information provided on this form was previously submitted under manufacturing report number 0001825034-2017-03387.

Manufacturer Narrative

(b)(4). Concomitant product(s): 104302 704990 acet lnr h-wall 28mm id sz b. 103507 564860 ti acet screw 5. 0x40mm. 103511 655230 ti acet screw 6. 5 x 25mm. 103507 635090 ti acet screw 5. 0x40mm. 103512 546610 ti acet screw 6. 5 x 30mm. 103554 664250 univ hexlc shl 54mm b. 162313 582950 bi-metric pc 13x145mm t1. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06190.

Event Description

It was reported patient¿s hip was revised approximately 29 year post-implantation due to instability dislocation. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 28MM DIA TI MOD HEAD ION STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6778094
• MDR Text Key: 119231667
• Report Number: 0001825034-2017-06197
• Device Sequence Number: 1
• Product Code: LZY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK915548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 163145
• Device Lot Number: 608560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/22/2017
• 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 Treatment Data

Date Received: 08/09/2017 Patient Sequence Number: 1