MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: pt-113950, pt hybrid glen post regenerex, lot # 724320, catalog #: 406669, stn pn thd tip.125x2.5in 2pk, lot # 745160, catalog #: 113633, comp primary stem 13mm mini, lot # 180300, catalog #: 118001, versa-dial/comp ti std taper, lot # 497590, catalog #: 113046, versa-dial 46x24x47 hum head, lot # 753240.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained 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.Unknown if product will be returned.
Event or Problem Description
It was reported that the patient received an initial left shoulder arthroplasty approximately a year ago.Subsequently a revision occurred about 2 months ago due to a loosening baseplate and bone erosion.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d1, d4 (item, lot, exp date, udi), d6, g4, g5, h1, h2, h4, and h10 d11 - medical product: catalog #: 115370, comp rvs tray co 44mm, lot # 471960.Catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 270080.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 87550.Catalog #: 180559, comp nlk scr 3.5hex 4.75x25 st, lot # 135360.Catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 352670.Catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 339050.Catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 869170.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 or Problem Description
It was further reported that the patient had an initial left total shoulder arthroplasty approximately two (2) years ago.The patient was revised about a year ago due to subscapularis failure (covered under a different complaint).Then a month later the patient was revised due to a loose baseplate.Then again about four (4) months later for the second part of the two stage revision of the left shoulder.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as the x-rays show there is lucency along the glenoid implant fixation screws reflecting osteolysis and loosening of the glenosphere.The baseplate component was loose as well while the humeral is not.Bone quality is noted to be mildly osteopenic.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9307716
• Report Number: 0001825034-2019-05038
• Device Sequence Number: 13996159
• Product Code: KWS
• UDI-Device Identifier: 00880304462489
• UDI-Public: (01)00880304462489
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K120121
• 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,Followup
• Report Date (Section B): 04/30/2020

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: 010000589
• Device Lot Number: 605420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 04/28/2020; 04/30/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 04/30/2020; 05/01/2020
• 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: 105