MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM MOD HD COCR STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); No Code Available (3191); Subluxation (4525)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.(b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00110 / 00111).

Event Description

It was reported that patient underwent right total hip arthroplasty on (b)(6), 2015.Subsequently, patient underwent non-surgical repositioning on (b)(6), 2015 due to luxation.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

There is no update to the prior event description provided.

• Brand Name: 32MM MOD HD COCR STD
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5359944
• MDR Text Key: 35656094
• Report Number: 0001825034-2016-00110
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 05019279400799
• UDI-Public: (01)05019279400799(17)250511(10)00J3551685
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024

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: 163669
• Device Lot Number: 00J3551685
• 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?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided; 04/26/2024
• Supplement Dates FDA Received: 02/12/2016; 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 62 KG