MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 16 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
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.Device not returned.
Event or Problem Description
It has been reported "broken cone conical stem, 2 yrs after implantation".
Event or Problem Description
It has been reported "broken cone conical stem, 2 yrs after implantation.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a restoration modular stem was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection of the returned device confirms that the device was fractured.The damage is consistent with fatigue accumulation in the stem ultimately ending in a fatigue fracture of the stem requiring revision.Clinician review: a review of the provided medical records by a clinical consultant indicated the following: "it is difficult to know the etiology of the fracture.It could be due to technical surgical factors in that the distal portion of the stem may have been solidly fixed and the upper portion of the stem with lack of support creating a cantilever type affect which could cause fracture.The fact that the greater trochanter was fractured and not in continuity with the femur means there was abnormal stress on the proximal femur which also could have contributed.An xray showing the post revision construct would be helpful.Conclusion of assessment: as mentioned above the femoral stem failed at 2 1/2 years after implantation.Causative factors could be lack of complete fixation and abnormal stress on the stem due to lack of abductor musculature.While i can confirm that the failure due to fracture occurred, i cannot confirm with certainty, the root cause of the failure.Surgical technique factors, local musculature factors and patient factors such as bmi and activity level must be considered." 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 fracture of the restoration modular stem.Visual inspection of the returned device confirms that the device was fractured.The damage is consistent with fatigue accumulation in the stem ultimately ending in a fatigue fracture of the stem requiring revision.A review of the provided medical records by a clinical consultant indicated the following: "it is difficult to know the etiology of the fracture.It could be due to technical surgical factors in that the distal portion of the stem may have been solidly fixed and the upper portion of the stem with lack of support creating a cantilever type affect which could cause fracture.The fact that the greater trochanter was fractured and not in continuity with the femur means there was abnormal stress on the proximal femur which also could have contributed.Causative factors could be lack of complete fixation and abnormal stress on the stem due to lack of abductor musculature.While i can confirm that the failure due to fracture occurred, i cannot confirm with certainty, the root cause of the failure.Surgical technique factors, local musculature factors and patient factors such as bmi and activity level must be considered." 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.

• Brand Name: MOD CON DIST STEM 16 X 155 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12384651
• Report Number: 0002249697-2021-01476
• Device Sequence Number: 4648111
• Product Code: LPH
• UDI-Device Identifier: 04546540643742
• UDI-Public: 04546540643742
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 08/31/2023
• Device Model Number: 6276-7-016
• Device Catalogue Number: 6276-7-016
• Device Lot Number: CAXX234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White