MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; INVERSE/REVERSE SCREW, 4.5 ¿ 42MM

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: cement; catalog# : 85225; lot# : 402282, musculoskeletal transplant fnd; catalog# : 81207; lot# : n/s, base plate 25 mm post length +2 mm lateral offset uncemented; catalog# : 00434902502; lot# : 63685438, glenosphere 36 mm diameter; catalog# : 00434903611; lot# : 63736824, comp rvs tray co 44mm; catalog# : 115370; lot# : 795950, arcom xl 44-36 std +3 hmrl brg; catalog# : xl-115364; lot# : 927530.The manufacturer received x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and revision surgery has been planned for radiolucency.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the anatimical shoulder reverse screw system was implanted on (b)(6) 2017 (removal of hemiarthroplasty, placement of reverse tsa).Ct scan performed on (b)(6) 2019 and planned for revision on (b)(6) 2019 due to radiolucency about the inferior glenosphere screw (2x).Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: single ap scout view of a chest ct examination dated on (b)(6) 2019 was reviewed by hcp: assessment of imaging: the scout view is of limited quality as the low dose technique results in extensive artifact along the metal arthroplasty components.There is lucency along the glenoid screws.There is suspected loosening and displacement of the glenoid component of the reverse type shoulder arthroplasty as the glenosphere surface is now projecting superolaterally in the supine position.There is no evidence of humeral implant loosening or fracture and the implants are grossly aligned but subluxed.Impressions: lucency along the glenoid fixation screws and suspected loosening and displacement of the left shoulder glenoid component of the reverse type arthroplasty as noted.It should be noted that this is a scout view from a ct exam and is of very limited quality.There is malalignment due to suspected loosening and migration of the glenoid implant.The implant sizes appear appropriate.Bone quality appears osteopenic.As a result of the glenoid implant migration, there is subluxation at the implant articulation.No subsidence is seen.Surgical notes of implantation surgery: the surgical notes were reviewed by hcp and concluded on the following findings: left shoulder failed hemiarthroplasty, removal of hemi, placement of reverse total shoulder, general anesthesia, blood loss: 100 ml, removed head of proximal humeral implant, debrided around stem, 180 degree capsular release performed, scar on glenoid removed and debrided, obtained good bleeding, cultures taken ¿ no results provided, no complications.Review of further medical data by hcp was performed an concluded on the following findings: on (b)(6) 2019 ct scan performed, lucency about the inferior glenosphere screw, no cement used on baseplate / glenoshere in 2017 case per rep, no trauma reported, pmi request for upcoming shoulder revision on (b)(6) 2019.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Product compatibility: the product combination was approved by zimmer biomet.However, competitor's instrumentation was used for glenoid preparation.Conclusion: it was reported that the anatimical shoulder reverse screw system was implanted on (b)(6) 2017 (removal of hemiarthroplasty, placement of reverse tsa).Ct scan performed on (b)(6) 2019 and planned for revision on (b)(6) 2019 due to radiolucency about the inferior glenosphere screw (2x).Based on the investigation the reported event can be confirmed.The review of the x-ray confirmed that lucency around the glenoid fixation screws.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• Common Device Name: INVERSE/REVERSE SCREW, 4.5 ¿ 42MM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9671006
• Report Number: 0009613350-2020-00047
• Device Sequence Number: 319501
• Product Code: KWT
• UDI-Device Identifier: 00889024483057
• UDI-Public: 00889024483057
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2908167
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: 104