MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER HUMERAL HEAD, 52/19; ANATOMICAL PRESS-FIT HUMERAL STEM

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: anatomical shoulder humeral stem, uncemented, 14, ref# 01.04201.142, lot#:2511328.Anatomical shoulder, glenoid, pegged, cemented, l, ref# 01.04214.400, lot#: 2515808.The following reports are associated with this event: 0009613350-2018-00341 and 0009613350-2018-00343.The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.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.Additional information has been requested and is currently not available.It was however reported that the patient is not willing to share further information as soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted with an as shoulder system and suspects allergic reactions.No revision plans are reported.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: 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: allergic reaction.Event description: it was reported that a patient was implanted with an as shoulder system on an unknown date and suspects allergic reactions.No revision plans are reported.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using sap dfmea: adverse body reaction (eg.Cancer, allergies, etc.) due to material not biocompatible.Not possible: biocompatibility specification and material compatibility specification validates the compatibility of the materials.Adverse body reaction due to bioincompatible due to harmful leachables from implant material.Not possible: biocompatibility specification and material compatibility specification validates the compatibility of the materials.Loosening / allergic reaction due to corrosion of particulate metal, due to fretting, leads to adverse body reaction.Possible: it is unknown if corrosion of the materials occurred.Conclusion: patient suspects a possible allergic reaction towards the implants.Investigation of the case shows the chamical compostion of the implants used as follows: ref#: (b)(4) is consisting of the alloys protasul-100 (mainly titanium, aluminum and niobium) and protasul-21wf (mainly cobalt, chromium, molubdenum and carbon).Ref#: (b)(4) is consisting of the alloy x5crnimo17-12-2 (mainly chromium, nickel and molubdenum) and polyethylene.Ref#: (b)(4) is consisting of the alloy protasul-21wf (mainly cobalt, chromium, molubdenum and carbon).It is possible that the patient has an allergy towards one of those elements indicated above.Nickel allergy is common among some people, therefore the patient has to go through an allergy test to learn what elements the patient is allergic to.Without knowing this medical data it is not possible to conclude a root cause for this complaint.Nevertheles,, raw material certificate is reviewed and confirmed that the device was manufactured according to the material specifications.Review of the device history records for the product did not identify any deviations or anomalies related to the reported event.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 gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER HUMERAL HEAD, 52/19
• Type of Device: ANATOMICAL PRESS-FIT HUMERAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7330249
• MDR Text Key: 102083928
• Report Number: 0009613350-2018-00344
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK003801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.04212.520
• Device Lot Number: 2444900
• Other Device ID Number: 00889024285798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other