MAUDE Adverse Event Report: ZIMMER GMBH HUMERAL ANCHOR UNCEMENTED M

Catalog Number 01.04555.120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/02/2015

Event Type  Other  

Event Description

It was reported that the patient was implanted a humeral anchor uncemented m on the left side on (b)(6) 2014.It was reported that the patient have pain with movement of the operative shoulder with limited range of motion.Surgeon to assess supraspinatus.They are unsure if this has any relation to the device.

Manufacturer Narrative

The manufacturer did not receive devices or other source documents for review as the patient has not been revised.Three x-rays were provided.The device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Manufacturer Narrative

No trend is identified.The product combination used is approved by zimmer.The device is not at hand as it is still in-vivo, thereof a technical investigation is not possible to perform.Three undated x-rays were provided showing the left shoulder.The x-rays of the implanted shoulder prosthesis are inconspicuous, without evidence of implant failure or signs of loosening.No radiological relevant information is provided to be compared with the limited range of motion reported by the surgeon.It is reported that the patient was feeling pain and had a limited range of motion.However, due to inconspicuous x-rays it is not possible to asses an impingement which may be the cause of limited range of motion.Moreover, surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Patient f actors that may affect the performance of the components such as bone quality, type of activity (low impact vs.High impact), and relevant medical history are unknown.Due an unclear involvement of the product in the reported event (pain is not related to any specific cause in the dfmea), is not possible to perform a meaningful selection of risk/s for the patient.However, all possible causes related to the issues reported are listed in the dfmeas.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.

• Brand Name: HUMERAL ANCHOR UNCEMENTED M
• Type of Device: HUMERAL ANCHOR UNCEMENTED M
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 57426761
• MDR Report Key: 4818413
• MDR Text Key: 19640363
• Report Number: 9613350-2015-00628
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 01.04555.120
• Device Lot Number: 2738432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 95