MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 8MM HUM FRACT STEM PPS; EXTREMITIES, IMPLANT

Model Number N/A

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

Patient Problems Tissue Damage (2104); Tingling (2171); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item#115370; lot# 666100; comp rvs tray co 44mm; item# xl-115363; lot# 298700; arcom xl 44-36 std hmrl brng; item# 115310; lot# 892640; comp rvrs shldr glnsp std 36mm; item# 010000589; lot# 409640; comp rvrs 25mm bsplt ha+adptr; item# 115396; lot# 783340; comp rvs cntrl 6.5x30mm st/rst; item# 180552; lot# 527240; comp lk scr 3.5hex 4.75x25 st; item# 180552; lot# 900780; comp lk scr 3.5hex 4.75x25 st; item# 180550; lot# 563630; comp lk scr 3.5hex 4.75x15 st.Foreign: event occurred in (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03809, 0001825034-2020-03811, 0001825034-2020-03812, 0001825034-2020-03814, 0001825034-2020-03815, 0001825034-2020-03816, 0001825034-2020-03817, 0001825034-2020-03818.Remains implanted.

Event Description

It was reported that a patient underwent an initial left reverse shoulder procedure.Subsequently, the patient claims to be experiencing tingling, numbness, loss of range of motion, torn rotator cuff and nerve damage.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.

Event Description

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

• Brand Name: COMPR 8MM HUM FRACT STEM PPS
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10682951
• MDR Text Key: 211447659
• Report Number: 0001825034-2020-03813
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304591547
• UDI-Public: (01)00880304591547
• Combination Product (y/n): N
• PMA/PMN Number: K140652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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 Model Number: N/A
• Device Catalogue Number: 12-113558
• Device Lot Number: 224320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 48