MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REST HA -5 RED NK 145MM STEM 5X11MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	6522-0511
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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 reported lot.
Event or Problem Description
It was reported the patient's left hip was revised due to a broken restoration stem.
Event or Problem Description
It was reported the patient's left hip was revised due to a broken restoration stem.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a restoration modular stem was reported.The event was confirmed based on review of the medical records by a clinical consultant.Device evaluation and results: not performed as product was not returned a review of the provided medical records and/or x-rays by a clinical consultant indicated: in this case there was a mechanical failure of a fully coated stem used to treat a periprosthetic fracture.There is no evidence of any patent related factors such as increased patient weight, young age or higher activity level.No clinical history of trauma was provided.Based on the single image, the femoral component was well-fixed distally and not proximally, creating a stress-riser.Cantilever bending forces caused the stem to give out.Mechanical failure of total hip implants has been described in the literature and is not common.Often an anatomic factor contributing to the failure can be identified.In this case, it could be the stem not getting fixation proximally.Without an examination of a retrieved implant, i cannot say that this event was implant related.The lot code should be checked in the database to ensure there were no other similar events.Although an unlikely cause, it would be worth confirming there was no traumatic event.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The reported stem fracture was confirmed based on review of the medical records by a clinical consultant.Clinician review indicated that there is no evidence of any patent related factors such as increased patient weight, young age or higher activity level.No clinical history of trauma was provided.Based on the single image, the femoral component was well-fixed distally and not proximally, creating a stress-riser.Cantilever bending forces caused the stem to give out.Mechanical failure of total hip implants has been described in the literature and is not common.Often an anatomic factor contributing to the failure can be identified.In this case, it could be the stem not getting fixation proximally.The root cause of the event could not be determined because insufficient information was provided.Additional information, including implant evaluation and confirming that there was no traumatic event is required to further investigate this event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: REST HA -5 RED NK 145MM STEM 5X11MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7722594
• Report Number: 0002249697-2018-02321
• Device Sequence Number: 1050335
• Product Code: MEH
• UDI-Device Identifier: 07613327018745
• UDI-Public: 07613327018745
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 6522-0511
• Device Lot Number: 7D3KPT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 66