MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-36; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: glenosphere 36 mm diameter, item#: 00434903611, lot#: 64083359.Base plate 15 mm post length uncemented, item#: 00434901500, lot#: 64141404.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not 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.(b)(4).
Event or Problem Description
The patient was implanted on an unknown side and underwent revision surgery due to stem loosening and infection.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.Event description: it was reported that the patient received a shoulder implant on (b)(6) 2019 due to a 4-fragment fracture of the proximal epiphysis of the right humerus with a head split of the upper articular surface and a large tissue compression defect.Fifteen months after implantation, loss of external rotation was confirmed on clinical examination, elevated crp-value on laboratory testing, and inflammation on ct and radiographic examination.Additionally, loosening was reported.The patient underwent a two-stage (spacer) revision due to mrse.Initial treatment with vancomycin, teicoplanin and doxycycline.After reimplantation, treatment with doxycycline and rifampicin.Review of received data: no medical data relevant to the case has been received.Product evaluation: no product was returned.Review of product documentation: device purpose: this device is intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr: no ncr with a potential correlation to the reported event was found.Sterilization certificate: the sterilization specification of the devices certifies the suitability of sterilization.The irradiation certificates of the affected lot numbers have been reviewed and were found to be according to specifications.Conclusion: it was reported that the patient received a shoulder implant on (b)(6) 2019 due to a 4-fragment fracture of the proximal epiphysis of the right humerus with a head split of the upper articular surface and a large tissue compression defect.Fifteen months after implantation, loss of external rotation was confirmed on clinical examination, elevated crp-value on laboratory testing, and inflammation on ct and radiographic examination.Additionally, loosening was reported.The patient underwent a two-stage (spacer) revision due to mrse.Initial treatment with vancomycin, teicoplanin and doxycycline.After reimplantation, treatment with doxycycline and rifampicin.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 non-conformance or a complaint out of box (coob).The irradiation certificates of the affected lots were reviewed and found to be in compliance with specifications.In addition, no trend regarding infection was observed in the affected product families.Therefore, it is unlikely that an unsterile device caused the infection that occurred 15 months after implantation.The reported loosening could not be evaluated due to lack of information.It is possible that the loosening was a result of the infection.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2020-00350-1, 0009613350-2020-00353-1, 0009613350-2020-00352-1, 0009613350-2020-00354-1.

• Brand Name: ANATOMICAL SHOULDER, REVERSE, SCREW SYSTEM, 4.5-36
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10343302
• Report Number: 0009613350-2020-00351
• Device Sequence Number: 10965323
• Product Code: HSD
• UDI-Device Identifier: 00889024483040
• UDI-Public: 00889024483040
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.036
• Device Lot Number: 2941142
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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