MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0, RETRO, +6 MM MEDIAL OFFSET; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number N/A

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Swelling/ Edema (4577)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: base plate 15 mm post length uncemented; catalog#: 00434901500; lot#: 64141438.Glenosphere 36 mm diameter; catalog#: 00434903611; lot#: 64077884.Therapy date: (b)(6) 2020.The manufacturer received 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.(b)(4).

Event Description

Patient was implanted on the left side and underwent a revision surgery due to swelling, pain and suspected infection.As revision kit and the tm glenoid instruments were used to aid removal.

Event Description

Investigation results are now available.

Manufacturer Narrative

1.Event description: patient was implanted on (b)(6) 2019 and underwent revision surgery on (b)(6) 2020 due to swelling, pain and suspected infection.Samples were also taken at revision surgery.Harm: s3 - infection, moderate localized hazardous situation: patient¿s anatomy is exposed to agents/substances of unknown origin.2.Review of received data: no medical data has been provided.Patient information has not been provided due to country regulations.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com 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(s): no ncr with a potential correlation to the reported event was found.Sterilization certificate: the gamma 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.5.Conclusion: patient was implanted on (b)(6) 2019 and underwent revision surgery on (b)(6) 2020 due to swelling, pain and suspected infection.Samples were also taken at revision surgery.Medical records such as laboratory results were not provided.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 lot numbers have been reviewed and were found to be according to specifications.Based on the missing medical records, the suspected infection could not be confirmed.Therefore, a root cause could not be found for the reported revision.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).

Manufacturer Narrative

(b)(4).G-2 foreign: united kingdom.This follow-up report is being submitted to relay additional and/or corrected information.Products were returned for investigation and all the devices were visually inspected.No signs of heavy damage or part deformation on any of the items.Little scratches on the surfaces of the humeral stem, on the glenosphere and the humeral cup.Bone ongrowth on the pin and surface of the base plate.Review of the device history records identified no deviations or anomalies during manufacturing.No definitive root cause can be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0, RETRO, +6 MM MEDIAL OFFSET
• Type of Device: ANATOMICAL SHOULDER INVERSE/REVERSE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11045684
• MDR Text Key: 222639933
• Report Number: 0009613350-2020-00608
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024479401
• UDI-Public: (01)00889024479401(17)230930(10)2967421
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.106
• Device Lot Number: 2967421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 06/08/2021; 10/13/2022
• Supplement Dates FDA Received: 06/21/2021; 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention