MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RC ARTHRORIVET; STAPLE, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/15/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event.

Event Description

It has been reported that beginning approximately ten (10) weeks post-implantation with rotator cuff repair, the patient suffered recurrent pain and loss of rom to the l shoulder.Approximately four (4) months post-implantation, the patient underwent an arthroscopy procedure and revision to repair the rotator cuff as it was again torn.The attachment of the rotator cuff fixation was noted to be good, however the tissue was split.Patient's shoulder pain and limited mobility has reportedly still been persistent to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 concomitant medical products : 905802, rc arthrorivet, lot 704640 (quantity 2) , 905802, rc arthrorivet, lot 169260.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11270, 0001825034 - 2019 - 01629, 0001825034 - 2019 - 01630.

Event Description

It was reported that the patient has been experiencing pain for approximately 9 years, since her initial l arthroscopy and rotator cuff repair procedure.Devices have not been revised.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was able to be confirmed from review of medical records.It was noted that approximately 3 months post initial rotator cuff repair with arthrorivet devices, the patient had 2 more devices implanted due to subsequent retear.It was noted on an er visit approximately 7 years later, that the patient had fallen and aggravated an old l shoulder injury, and she was having pain.Per mri report approximately 8.5 years post implantation of the 2nd set of devices, there was a full-thickness tear of the supraspinatus tendon approximately 3 cm in size of the l shoulder.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not be determined; however, it is noted that patient trauma (falls) may have been a contributing factor.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: RC ARTHRORIVET
• Type of Device: STAPLE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8159585
• MDR Text Key: 130181191
• Report Number: 0001825034-2018-11269
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K951658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2019

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: 04/20/2014
• Device Model Number: N/A
• Device Catalogue Number: 905802
• Device Lot Number: 169260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 03/21/2019; 04/16/2019
• Supplement Dates FDA Received: 04/09/2019; 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 51