MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SML FEM STEM 8 X 102MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6485-3-008
Medical Device Problem Codes	Corroded (1131); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Cancer (3262)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sale rep.That gmrs stem broke in patient body.Patient is a long-term osteosarcoma survivor.He was walking and suddenly heard a scratch sound, followed by severe left thigh pain.He was unable to bear weight thereafter.Prior to this, patient was able to do straight leg raises and walk pain free.Broken implant (6485-3-008) could not be removed from the patient.Please explain why the broken part was cemented in the canal.Patient has an amputation leg due to a fractured stem? please confirm.Yes.And also due to financial challenge for the revision of operation cost.
Additional Manufacturer Narrative
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.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.Catalog numbers and lot codes of other devices listed in this report: gmrs extension piece 140mm 6495-6-140.Lot: n4b7s.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.The device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and corrosion involving a mrs stem was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis: "images show the mrs straight stem with fracture location highlighted by the arrow.On visual examination, the fracture was observed at the mid-stem region, approximately 92 mm from the male taper end of the stem.Also included in the images is the extension piece.[.] another image shows surface material damage and discolouration within the female taper of the proximal end of the extension piece, consistent with in-vivo wear." material analysis: a material analysis was performed and concluded the following: "review of mrs straight stem, catalog # 6485-3-008, lot code 183611b and gmrs extension piece, catalog # 6495-6-140, lot code n4b7s, confirmed fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrs straight stem at the mid-stem region.The fracture was observed to have propagated in fatigue with final fracture in overload.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion, consistent with in-vivo wear.No manufacturing related defects were observed on the examined areas of the components." clinician review: no medical records were received for review with a clinical consultant.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 amputated due to fracture of the mrs stem.A material analysis was performed on the returned devices and concluded the following: "review of mrs straight stem, catalog # 6485-3-008, lot code 183611b and gmrs extension piece, catalog # 6495-6-140, lot code n4b7s, confirmed fracture of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the mrs straight stem at the mid-stem region.The fracture was observed to have propagated in fatigue with final fracture in overload.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion, consistent with in-vivo wear.No manufacturing related defects were observed on the examined areas of the components." further information such as pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the sale rep.That gmrs stem broke in patient body.Patient is a long-term osteosarcoma survivor.He was walking and suddenly heard a scratch sound, followed by severe left thigh pain.He was unable to bear weight thereafter.Prior to this, patient was able to do straight leg raises and walk pain free.Broken implant (6485-3-008) could not be removed from the patient.Please explain why? the broken part was cemented in the canal.Patient has an amputation leg due to a fractured stem? please confirm.Yes.And also due to financial challenge for the revision of operation cost.

• Brand Name: MRS SML FEM STEM 8 X 102MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15962984
• Report Number: 0002249697-2022-01803
• Device Sequence Number: 11990122
• Product Code: KRO
• UDI-Device Identifier: 07613327048285
• UDI-Public: 07613327048285
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 6485-3-008
• Device Catalogue Number: 64853008
• Device Lot Number: 183611B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male