MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to the restoration modular distal stem breaking in the middle of the distal stem.Surgeon reported a possible contributing factor being the selected stem was too small for the patient's anatomy (incorrect selection, not incorrect size).The modular stem and femoral head were revised.Rep confirmed there are no allegations against the revised femoral head or proximal body.
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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a restoration modular stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results product evaluation and results: not performed as no product was returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event date: (b)(6) 2013 (opened (b)(6) 2013), (b)(6) 2015 (opened (b)(6) 2015), (b)(6) 2021 (opened (b)(6) 2021), anatomic site: left hip.Confirmation: a revision surgery for infection could be confirmed (event date (b)(6) 2013).The incidence of a broken extractor could not be confirmed (event date (b)(6) 2015).Revision surgery for a broken restoration modular stem could not be confirmed, but the incidence of a fractured stem was noted and described in an office note as was a plan for revision surgery (event (b)(6) 2021).Root cause: the root cause of revision for event date 02/11/2013 was a deep hip infection.The root cause for event date (b)(6) 2015 cannot be determined without additional information and confirmation of the event.The root cause for event date (b)(6) 2021 was likely as described, cantilever bending and fatigue metal fracture, but this event and root cause cannot be determined without additional medical information and perhaps examination of the explant if/when available.-product history review: review of the device history records indicate the 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.Conclusion: a revision surgery for infection could be confirmed (event date (b)(6) 2013).The incidence of a broken extractor could not be confirmed (event date (b)(6) 2015).Revision surgery for a broken restoration modular stem could not be confirmed, but the incidence of a fractured stem was noted and described in an office note as was a plan for revision surgery (event (b)(6) 2021).Root cause: the root cause of revision for event date 02/11/2013 was a deep hip infection.The root cause for event date (b)(6) 2015 cannot be determined without additional information and confirmation of the event.The root cause for event date 12/16/2021 was likely as described, cantilever bending and fatigue metal fracture, but this event and root cause cannot be determined without additional medical information and perhaps examination of the explant if/when available.
Event or Problem Description
It was reported that the patient's left hip was revised due to the restoration modular distal stem breaking in the middle of the distal stem.Surgeon reported a possible contributing factor being the selected stem was too small for the patient's anatomy (incorrect selection, not incorrect size).The modular stem and femoral head were revised.Rep confirmed there are no allegations against the revised femoral head or proximal body.

• Brand Name: MOD CON DIST STEM 15 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 13222533
• Report Number: 0002249697-2022-00059
• Device Sequence Number: 1701152
• Product Code: LPH
• UDI-Device Identifier: 04546540643735
• UDI-Public: 04546540643735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K013106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 07/31/2019
• Device Model Number: 6276-7-015
• Device Catalogue Number: 6276-7-015
• Device Lot Number: CAXR40EA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 108 KG