MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL HUMERAL BUSHING & AXLE KIT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 6487-K-001

Device Problems Break (1069); Naturally Worn (2988)

Patient Problems Ambulation Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "broken mrs axle pin.Revision surgery took place on (b)(6) 2021.".

Event Description

As reported: "broken mrs axle pin.Revision surgery took place on (b)(6) 2021.".

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving a hmrs axle was reported.The event was confirmed based on provided photo and clinician review.Clinician review also revealed and confirmed wear of a distal humeral bearing insert and metallosis.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photo presented a recently explanted axle which was fractured and a severally worn distal humeral bearing insert.The reported event is confirmed.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "the complaint of a broken axle is confirmed.The root cause for this material failure is wear of the polyethylene bushing (distal humeral bearing insert) leading to metal on metal articulation between the humeral and ulna components.The picture of the worn polyethylene bushing shows metal staining on the bushing and the x-rays show evidence of metallosis in the soft tissues.Both of these findings corroborate the proposed root cause for this pi." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to broken mrs axle pin.The provided photo confirmed that the axle was fractured and the explanted distal humeral bearing insert was severally worn.Clinician review of provided medical records indicated that the material failure (i.E.Axle pin fracture) is caused due to wear of the polyethylene bushing (i.E.Distal humeral bearing insert) leading to metal on metal articulation between the humeral and ulna components.The picture of the worn polyethylene bushing shows metal staining on the bushing and the x-rays show evidence of metallosis in the soft tissues.Both of these findings corroborate the proposed root cause for this pi.However, the root cause of the poly wear could not be determined due to insufficient information.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DISTAL HUMERAL BUSHING & AXLE KIT
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11342719
• MDR Text Key: 232421820
• Report Number: 0002249697-2021-00294
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07613327139266
• UDI-Public: 07613327139266
• Combination Product (y/n): N
• PMA/PMN Number: K062845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 6487-K-001
• Device Catalogue Number: 6487-K-001
• Device Lot Number: J54A1V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR