MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY RINGLOC ACETABULAR LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, (still implanted).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant product(s) - e-poly ringloc acetabular liner p/n ep-108222 l/n 895150; tri-spike shell apical hole p/n 101001 l/n 506240; modular head component p/n 163668 l/n 679220; modular lateralized taperloc femoral stem p/n 11-103200 l/n 217820.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-05770, 0001825034-2017-05771, 0001825034-2017-05772, 0001825034-2017-05773.Still implanted.

Event Description

It was reported patient underwent left hip arthroplasty, stiffness in hands, no feeling around incision and leg, pain and stiffness when sitting a certain way.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.The following sections were updated: date of implantation, reporter name and address.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.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.

• Brand Name: E-POLY RINGLOC ACETABULAR 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: 6764745
• MDR Text Key: 81780416
• Report Number: 0001825034-2017-05770
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: N/A
• Device Catalogue Number: EP-108222
• Device Lot Number: 895150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 10/03/2017; 11/08/2017
• Supplement Dates FDA Received: 10/14/2017; 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• 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 Weight: 59