MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-6; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item: anatomical shoulder humeral stem, unce item#: 01.04201.103 lot#: 2889465 item: anatomical shoulder reverse, humeral cup item#: 01.04223.100 lot#: 2939555 x-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.An e-mail requesting the following additional information was sent on february 27, 2019 to the appropriate representatives.The availability of the affected product(s) (non-availability with a rationale).Surgical reports.Did a delay in the procedure over 30 minutes occur that was related to the event? time surgery was extended.Were there any contributing conditions related to the event? (ex: trauma, illness, previous surgery, related non-compliance, patient anatomy).Was the surgical technique for the product utilized? 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 the patient underwent a revision surgery due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: dislocation.Event description: it was reported that the anatomical shoulder endoprosthesis was implanted on (b)(6) 2018 and revised on (b)(6) 2019 due to dislocation.Review of received data: one undated x-ray is received for investigation.Humeral stem is in position, attached to the cup.Humeral cup seems to be not in articulation with the glenoid anymore.It is unknown if the pe cup is still fixed in the cup.Based on only one x-ray available it is not possible to comment more.In the x-ray also a ring is noticed, however, it is unknown from where it comes from.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The compatibility check between stem/cup/insert was performed and showed that the product combination was approved by zimmer biomet.However, the compatibility check between the insert and the glenoid could not be performed as the glenoid item is unknown.Surgical technique is not reviewed as no surgical report is available to compare with whether the surgical technique was followed or not.Conclusion: according the event patient underwent revision surgery due to dislocation after 2 months in-vivo time.No products neither surgical reports were received to make a detailed analysis of the complaint.Received x-ray confirms the dislocation event, however, positioning of the products cannot be analyzed well based on only one x-ray available.Other components of the shoulder prosthesis are also unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).Review of the device history records for the product did not identify any deviations or anomalies related to the reported event.Therefore, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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 0009613350-2019-00144.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL INSERT, PE, 36-6
• 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: 8432824
• Report Number: 0009613350-2019-00144
• Device Sequence Number: 1650864
• Product Code: KWS
• UDI-Device Identifier: 00889024481398
• UDI-Public: 00889024481398
• Combination Product (Y/N): N
• PMA/510(K) Number: K053274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.366
• Device Lot Number: 2942197
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention