MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item # 0104223033, item name anatomical shoulder reverse, screw system, 4.5- 33, lot # 2857358.The manufacturer received x-rays and 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.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.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 possible prosthetic joint infection.A subsequent surgery on the (b)(6) was due to the irrigation of the right shoulder and the debridement of an infected rtsa.
Additional Manufacturer Narrative
Investigation results were made available.Dhr-review: ref#: 01.04223.033 lot#: 2857358, yield: (b)(4), delivered: (b)(4).The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#: 01.04223.042 lot#: 2865695, yield: (b)(4), delivered: (b)(4).The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: infection.Event description: it was reported that the patient had a revision surgery on the 4th of april due to possible prosthetic joint infection.Review of received data: several x-rays were received and reviewed, medical records were provided and reviewed.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The product combination was approved by zimmer biomet.Instruction for use (ifu): in the ifu under the section warnings it is mentioned "re-use of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with the re-use of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents".Conclusion summary it was reported that the patient had a revision surgery on the 4th of april due to possible prosthetic joint infection.No products have been received for material analysis; therefore the condition of the component is unknown.The gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this product family.Therefore, it is highly unlikely that a disadvantageous product design favored or contributed to the infection.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, an exact root cause could not 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).The following reports are associated with this event: 0009613350 - 2019 - 00304 - 1.Note: this is a split case with warsaw: (b)(4).
Event or Problem Description
Investigation result are now available.
Additional Manufacturer Narrative
This case has been re-opened to enter additional information received.Should this additional information change the previous manufacturer's assessment of the case, an amended medical device report will be sent.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• Common Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8603586
• Report Number: 0009613350-2019-00303
• Device Sequence Number: 19566904
• Product Code: HSD
• UDI-Device Identifier: 00889024483033
• UDI-Public: 00889024483033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/07/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2865695
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 06/24/2019; 01/09/2020
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/26/2019; 02/07/2020
• 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