|
Model Number N/A |
Device Problem
Insufficient Information (3190)
|
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 remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: 905802, rc arthrorivet, lot 704640; 905802, rc arthrorivet, lot 169260 (quantity 2).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11269, 0001825034-2018-11270, 0001825034-2019-01629.
|
|
Event Description
|
It was reported that the patient has been experiencing pain and loss of range of motion 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.
|
|
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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|