MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY +10MM CO 44MM; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 972880, catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 576860, catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 278060, catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 563990, catalog #: 115320, comp rvrs shldr glnsp std 41mm, lot # 656860, catalog #: 180555, comp lk scr 3.5hex 4.75x40 st, lot # 954060, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 324510, catalog #: 113657, comp primary stem 17mm std, lot # 674420, catalog #: ep-115396, e1 44-41 std hmrl brng, lot # 549440.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: 0001825034-2020-01710, 0001825034-2020-01711.Remains implanted.
Event or Problem Description
It was reported that the patient underwent a right shoulder revision about two (2) months ago.Patient is experiencing an infection and is in the recovery phase from this surgery.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.
Event or Problem Description
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: COMP RVS TRAY +10MM CO 44MM
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9983840
• Report Number: 0001825034-2020-01712
• Device Sequence Number: 3836447
• Product Code: KWS
• UDI-Device Identifier: 00880304543195
• UDI-Public: (01)00880304543195
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: N/A
• Device Catalogue Number: 115378
• Device Lot Number: 080640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other