MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 9, 100 MM; ANATOMICAL SHOULDER SYSTEM

Model Number N/A

Device Problems Device Damaged by Another Device (2915); Patient Device Interaction Problem (4001)

Patient Problems Muscle Weakness (1967); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: anatomical shoulder, glenoid, pegged, cemented, s; catalog#: 01.04214.340; lot#: 2901466 anatomical shoulder domelock, humeral head, 46-16, r=26.1mm; catalog#: 01.04212.465; lot#: 2889557 anatomical shoulder domelock, dome, centric; catalog#: 01.04227.005; lot#: 2932677.Therapy date: (b)(6) 2021.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 an unknown side and underwent a revision surgery due to rotator cuff insufficiency.

Manufacturer Narrative

Additional information which was received on mar 24, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and underwent a revision surgery due to rotator cuff insufficiency.The patient was diagnosed with avascular necrosis of the humerus and had a previous ipsilateral proximal humerus fracture.The rotator cuff was functional.During surgery, the subscapularis tendon was released following the ¿lesser tuberosity osteotomy¿ approach.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent shoulder replacement on (b)(6) 2018 due to post-traumatic humeral head necrosis.During surgery, the subscapularis tendon was released upon osteotomy of the lesser tuberosity.On (b)(6) 2019 a right shoulder arthroscopy with biopsy was performed with no evidence of infection.The shoulder replacement was revised on (b)(6) 2021 due to rotator cuff insufficiency.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: the following radiographic evaluation was performed by a radiologist.Shoulder arthroplasty images on (b)(6) 2018 appear unremarkable.The reported incident of rotator cuff insufficiency is not confirmed or refuted radiographically.Secondary sign of rotator cuff insufficiency could be narrowing of the subacromial space, but this is not identified on the provided images in which the subacromial spacing is normal.The revision procedure performed on (b)(6) 2021 demonstrates normal appearance of a reverse shoulder arthroplasty which is anatomically aligned and otherwise unremarkable.Revision report from (b)(6) 2021: diagnosis: rotator cuff insufficiency condition after implantation of an anatomical right total shoulder prosthesis on (b)(6) 2018 for post-traumatic humeral head necrosis, condition after right shoulder arthroscopy with biopsy on (b)(6) 2019 with no evidence of infection.Indication: shoulder replacement in 2018.Postoperatively, the patient was never symptom-free.There was anterolateral shoulder pain.The patient can hardly use her right arm at all in everyday life.Radiologically, no evidence of loosening of the prosthesis during the course.We performed an arthroscopic biopsy in 2019, which revealed no evidence of an infection.On progression sonography, there is thinning of the subscapularis tendon and lnfraspinatus.It must be postulated that the prosthesis is not sufficiently dynamically centered due to rotator cuff insufficiency.Treatment: conversion from anatomic to inverse shoulder tep with biopsy and glenoid augmentation using allograft.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.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 the surgical technique 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.Conclusion: it was reported that the patient underwent shoulder replacement on (b)(6) 2018 due to post-traumatic humeral head necrosis.During surgery, the subscapularis tendon was released upon osteotomy of the lesser tuberosity.On (b)(6) 2019 a right shoulder arthroscopy with biopsy was performed with no evidence of infection.The shoulder replacement was revised on (b)(6) 2021 due to rotator cuff insufficiency.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 nonconformance or a complaint out of box (coob).The devices were not returned for examination; therefore, a product investigation could not be performed.According to the revision report provided, a revision due to rotator cuff insufficiency resulting in decentralization of the prosthesis, limited range of motion, and pain can be confirmed.During investigation no device related factors that may have caused or contributed to the rotator cuff insufficiency were identified.Therefore, it can be assumed that procedural and/or patient-related factors caused or contributed to the rotator cuff insufficiency.Nevertheless, an exact cause remains unknown.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).

• Brand Name: ANATOMICAL SHOULDER, HUMERAL STEM, CEMENTED, 9, 100 MM
• Type of Device: ANATOMICAL SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11555094
• MDR Text Key: 241819628
• Report Number: 0009613350-2021-00139
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024484894
• UDI-Public: 00889024484894
• Combination Product (y/n): N
• PMA/PMN Number: K142403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.04211.093
• Device Lot Number: 2930277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 54