MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X30MM ST/RST; SHOULDER PROSTHESIS

Catalog Number 115396

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Impaired Healing (2378)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).113629 232620, comp primary stem 9mm mini; 115370 732290, comp rvs tray co 44mm; xl-115363 169790, arcom xl 44-36 std hmrl brng; 115310 861840, comp rvrs shldr glnsp std 36mm; 010000589 284030, comp rvrs 25mm bsplt ha+adptr; 180552 542870, comp lk scr 3.5hex 4.75x25 st; 180553 425740, comp lk scr 3.5hex 4.75x30 st; 180552 261910, comp lk scr 3.5hex 4.75x25 st; 180555 030210, comp lk scr 3.5hex 4.75x40 st.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03425 0001825034-2019-03426 0001825034-2019-03427 0001825034-2019-03429 0001825034-2019-03430 0001825034-2019-03432 0001825034-2019-03433 0001825034-2019-03434 0001825034-2019-03435.Product remains implanted.

Event Description

It was reported that primary comprehensive reverse shoulder was performed and post-procedure approximately seven (7) weeks patient experienced surgical wound complication, stitch abscess requiring medical intervention of antibiotics and wound cleaning.No further complications reported during the study.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Review of medical records identified that the patient had hard lump small amount of pus drainage 2 days prior to visit.Had no drainage post antibiotic intake.Extremity warm well perfused, with normal pulses.Small area of redness < 0.5cm at the superior aspect of the incision without active drainage, streaking, or visible suture.No underlying deeper abscess is evident.Device history record (dhr) was reviewed and no discrepancies were found.Root cause could not 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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X30MM ST/RST
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8870535
• MDR Text Key: 153580784
• Report Number: 0001825034-2019-03431
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K182534
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115396
• Device Lot Number: 915970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 72