MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 40-6; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number: 0104223100, item name: anatomical shoulder reverse, humeral cup, retro, lot #: 2796018.Item number: 0104201103, item name: anatomical shoulder, humeral stem, uncemented, 10.5, 100 mm, lot #: 2897615.Item number: 0104223030, item name: anatomical shoulder reverse, screw system, 4.5-30, lot #: 2847000.Item number: 0104223030, item name: anatomical shoulder reverse, screw system, 4.5-30, lot #: 2899545.Item number: 47430902501, item name: pin 2.5 mm diameter, lot #: 63662169.Item number: 47430904601, item name: drill 2.5 mm diameter, lot #: 63697458.Item number: 47430906115, item name: base plate cannulated drill 6 mm diameter 15 mm length, lot #: 63594584.Item number: 00434901500, item name: base plate 15 mm post length uncemented, lot #: 63685447.Item number: 00434904011, item name: glenosphere 40 mm diameter, lot #: 63341753.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.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
It was reported that patient underwent revision surgery due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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).The following reports are associated with this event: 0009613350-2019-00483, 0009613350-2019-00484.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Trend analysis: no trend has been identified.Event description: it was reported that the patient was implanted with a shoulder prosthesis on (b)(6) 2017 and revised on (b)(6) 2018 due to dislocation.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the explants were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is also unknown.Moreover, as no x-rays have been recieved, the correct implant positioning cannot be assessed.Due to the lack of information, it cannot be assessed which components dislocated or whether a disassociation has happened.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause cannot be determined.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
Please refer to report 0009613350-2019-00483.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 40-6
• Common Device Name: ANATOMICAL SHOULDER INVERSE/REVERSE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8869940
• Report Number: 0009613350-2019-00483
• Device Sequence Number: 16913872
• Product Code: KWT
• UDI-Device Identifier: 00889024481428
• UDI-Public: 00889024481428
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K053274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2020

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.406
• Device Lot Number: 2696113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 03/18/2020
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/09/2019; 03/19/2020
• 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 Age: 61 YR
• Patient Weight: 89