MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY +5MM CO 44MM; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Joint Dislocation (2374)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 689070, catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 697730, catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 716640, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 887390, catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 887380, catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 465470, catalog #: 12-113560, compr 10mm hum fract stem pps, lot # 264740, catalog #: 405889, comp rvs 2.7mm dia drl, lot # 962330, catalog #: 405800, comp.Rev shldr 9 in steinmann, lot # 787430, catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 762300.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device had been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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, please see associated reports: 0001825034-2019-05390.
Event or Problem Description
It was reported that the patient underwent left reverse total shoulder arthroplasty about a month ago.Subsequently, patient was revised about 20 days later due to dislocation.
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.
Additional Manufacturer Narrative
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 +5MM CO 44MM
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9384494
• Report Number: 0001825034-2019-05392
• Device Sequence Number: 16696214
• Product Code: KWS
• UDI-Device Identifier: 00880304534148
• UDI-Public: (01)00880304534148
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115375
• Device Lot Number: 201700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 100