MAUDE Adverse Event Report: ZIMMER GMBH AFFIXUS NATURAL NAIL HUMERAL IMPL WIN GEN

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

X-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 Description

Patient was implanted on an unknown side and is being monitored due to migration and core lock failure.

Event Description

Patient was implanted on an unknown side and is being monitored for migration and core lock failure.

Manufacturer Narrative

Additional information which was received on nov 19, 2019.The manufacturer received x-rays, other source documents (surgical reports, photos) for review.Should additional information become available and / or the device(s) be returned for evaluation and 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).

Manufacturer Narrative

Additional information which was received on nov 19, 2019.The manufacturer received x-rays, other source documents (radiology report) for review.Should additional information become available and / or the device(s) be returned for evaluation and 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 left side and is being monitored for migration and core lock failure.

Event Description

Investigation is completed.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g4, g7, h10.Event description: it was reported that the affixus natural nail has been implanted on an unknown date.Three months after implantation it was found that corelock did not function, screws backed out and nail has failed proximally.Review of received data: x-ray review: 6 images left shoulder (ap, grashey, transcapsular, axillary view), dated (b)(6)2019: reduced and fixated chronic proximal humerus fracture.There has been a small amount of callus formation at the fracture margins in the interval, but the fracture line is not bridged with solid bone at this point in time.The intramedullary nail hardware is intact.The second proximal most screw is 6 mm proud.6 images right/left shoulder (ap, grashey, transcapsular views of both shoulders), dated (b)(6) 2019: right shoulder: no acute bony abnormalities, chronic postsurgical and degenerative changes of the acromioclavicular joint.Moderate glenohumeral degenerative joint disease.Degenerative subacromial and greater tuberosity enthesophytes.Left shoulder: similar amount of non-bridging callus formation at the proximal humeral diaphysis fracture site.Negative for new fractures.Moderate acromioclavicular and mild glenohumeral degenerative joint.- 5 images left shoulder (ap internal rotation, ap external rotation, grashey), dated (b)(6)2019: fracture at the proximal humerus with developing callus at the fracture site, which is increased in comparison to the imaging of (b)(6)2019.No change in alignment since previous imaging.3 images left shoulder (ap, grashey and y view), dated (b)(6)2019: interval hypertrophic callus formation at the fracture margins, but without evidence of any bony bridging across the fracture.This could indicate fracture motion.No interval changes in the proximal left humeral diaphysis fracture alignment.Moderate degenerative changes of the acromioclavicular and glenohumeral joints.5 images left shoulder, dated (b)(6)2019: there is a comminuted, mildly displaced fracture through the proximal diaphysis of the left humerus.There is mild medial displacement of the distal fragment.There is normal alignment of the shoulder joint without dislocation.Degenerative changes of the acromioclavicular joint.In addition, four x-rays, two intraoperative, two 3 months' postoperative, have been received: when comparing the 3 months' postoperative images to the intraoperative images, the most proximal screw is kinked which points to a screw fracture and the second and third most proximal screws are displaced.Patient data: (b)(6), born (b)(6)1939, male, bmi 25.5.Patient history: low demand elderly patient with oligotrophic non-union.Devices analysis: no product was returned to zimmer biomet for in-depth analysis, as it remained in-situ.Review of product documentation: all involved devices are intended for treatment.The compatibility check could not be performed due to unknown product identification.Dhr review could not be performed due to unknown product identification.Conclusion summary: it was reported that the affixus natural nail has been implanted on (b)(6)2019.Three months after implantation it was found that corelock did not function, screws backed out and nail has failed proximally.The nail has not been revised.Based on the received x-rays at least one screw fracture (most proximal screw) and displacement of the proximal screws can be seen.A failure of the nail could not be confirmed based on the available images.The product remained in-situ, therefore visual and dimensional evaluation could not be performed.Medical records have not been provided.The manufacturing records could not be reviewed, as reference and lot number of the parts are unknown.Therefore, neither the complaint history nor the compatibility check could be performed.Nevertheless, at this point no indication of a non-conformance or a complaint out of box (coob) is given.Based on the screw failures the complaint could be confirmed, nevertheless based on the given information were not able to identify an exact root cause for this issue.Additional information has been requested, but is not available.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: AFFIXUS NATURAL NAIL HUMERAL IMPL WIN GEN
• Type of Device: AFFIXUS NATURAL NAIL HUMERAL IMPL WIN GEN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9409272
• MDR Text Key: 169031758
• Report Number: 0009613350-2019-00762
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 88