MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN ARCOM TIBIAL BEARING; HIP PROSTHESIS

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 11/03/2008

Event Type  Injury  

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 patient mentioned in the journal article.The article was written by kjeld soballe, bjorn thorup and inger mechlenburg.

Event Description

Information was received based on review of a journal article titled, "total hip replacement in the congenitally dislocated hip using the paavilainen technique" which aimed to examine the radiographic and clinical results following total hip arthroplasty with the paavilainen technique performed over a 10-year period using cementless mallory-head acetabular components and arcom tibial bearing components manufactured by biomet; and to investigate diagnoses post-operatively.One patient was identified in the article that underwent hip arthroplasty on an unknown date.Patient follow-up results provided indicate that the patient dislocated two days post-operatively and was treated with closed reduction.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical products - unknown femoral head, unknown femoral stem, unknown mallory head acetabular cup, unknown arcom acetabular liner, all catalog#'s: ni all lot's#: ni.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.

Event Description

It was reported in the journal article that 3 patients experienced hip dislocations.One patient underwent a closed reduction procedure two days post-implantation.One patient experienced the dislocation due to malposition of the cup, and underwent an open reduction and repositioning of the cup two days post-implantation.One patient underwent an open reduction procedure approximately three months following the dislocation, and reported experiencing pain.No additional patient consequences were reported.

• Brand Name: UNKNOWN ARCOM TIBIAL BEARING
• Type of Device: HIP PROSTHESIS
• 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: 6081954
• MDR Text Key: 59285320
• Report Number: 0001825034-2016-04443
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2017; 04/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR