MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LOCKING SCREW 4.75X15MM; EXTREMITIES, IMPLANT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Numbness (2415)

Event Date 03/30/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item 115330, lot 256930, comp rvrs shdr glen bsplt +ha; item 115320, lot 742540, comp rvrs shldr glnsp std 41mm; item 115383, lot 468490, comp rvs cntrl scr 6.5x35mm st; item 118001, lot 414650, versa-dial/comp ti std taper; item 180501, lot 851420, comp locking screw 4.75x20mm; item 180504, lot 851970, comp locking screw 4.75x35mm; item 180503, lot 257240, comp locking screw 4.75x30mm; item 113633, lot 748600, comp primary stem 13mm mini; item xl-115366, lot 469720, acrom xl 44-41 std hmrl brng; item 115340, lot 659970, comp rvs hmrl ti tray 44mm.Multiple mdr reports were filed for this event.The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that patient underwent right reverse total shoulder arthroplasty.Subsequently, the patient developed progressive numbness in the right hand requiring an ulnar nerve transposition, approximately 4 months post surgery.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records which states that the patient underwent nerve transposition procedure.The patient has had several months history of numbness in the right small finger and beginning to affect the ulnar aspect of the ring finger.He had undergone a reverse shoulder arthroplasty a few months back and noticed the symptoms becoming more pronounced at that point with slowing of the ulnar nerve motor latency above the elbow.Device history record was reviewed and no discrepancies were found.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: 0001825034-2019-01836, 0001825034-2019-01838, 0001825034-2019-01839, 0001825034-2019-01840, 0001825034-2019-01843, 0001825034-2019-01844, 0001825034-2019-01845, 0001825034-2019-01846, 0001825034-2019-01849, 0001825034-2019-01850.

• Brand Name: COMP LOCKING SCREW 4.75X15MM
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8568552
• MDR Text Key: 143673618
• Report Number: 0001825034-2019-01841
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 180500
• Device Lot Number: 029310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other