MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN ARCOM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported event was identified during review of a journal article hirofumi oshima, md a, b, sakae tanaka, md, phd a, yoshio takatori, md, phd b, takeyuki tanaka, md a, hisatoshi ishikura, md a, toru moro, md, phd, et al.Clinical and radiographic outcomes of total hip arthroplasty with a specific liner in small asian patients: influence of patient-related, implant-related, and surgical factors on femoral head penetration.Concomitant product(s): unknown mallory cup.Unknown head.Unknown bi-metric stem.Source report: country: (b)(6).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record review was unable to be performed as the 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.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- 2017- 05798, 0001825034 - 2017 - 06480, 0001825034 - 2017 - 06488.

Event Description

It was reported in a journal article that 4 patients experienced deep vein thrombosis without associated pulmonary embolism, which were treated successfully with anticoagulants in each case.No further information is available.

• Brand Name: UNKNOWN ARCOM LINER
• 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: 6801035
• MDR Text Key: 82932740
• Report Number: 0001825034-2017-06481
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• 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): Other