MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 30MM; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	7030-6530
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate 100 devices were manufactured and accepted into final stock on 29 sep 2017 with no relevant reported discrepancies.There have been no similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Acetabular screw fracture identified at the 2 week follow up visit in doctor's office when radiology films were obtained.Patient had no complaints and was therefore placed on 20% partial non-weight bearing restrictions.Hardware examined as stable and well seated.Subsequent visits.
Event or Problem Description
Acetabular screw fracture identified at the 2 week follow up visit in doctor's office when radiology films were obtained.Patient had no complaints and was therefore placed on 20% partial non-weight bearing restrictions.Hardware examined as stable and well seated.Subsequent visits without complications or changes in hardware.Operative side: left.
Additional Manufacturer Narrative
An event regarding crack/fracture involving other hip screw and other hip screw was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: {.} procedure-related factors: supplemental cup fixation screw location right through the empty space of a bone cyst.Patient-related factors the bone cyst is associated with the degenerative hip disease for which total hip replacement was undertaken.Device-related factors: none.Diagnosis: supplemental cup fixation screw location right through the empty space of a bone cyst as remnant of the degenerative hip disease of the patient caused a loss of bone support around a major part of the screw thread section causing acute bending overload forces in the thread section contributing to a screw fracture exactly at the location of peak overload.The patient is symptom free while no adverse clinical consequences are to be expected in the near or more distant future and revision surgery is not to be expected.{.} device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 1 other similar event for the reported lot.Conclusion: the investigation concluded that the crack/fracture was caused by {.} supplemental cup fixation screw location right through the empty space of a bone cyst as remnant of the degenerative hip disease of the patient caused a loss of bone support around a major part of the screw thread section causing acute bending overload forces in the thread section contributing to a screw fracture exactly at the location of peak overload.{.}.

• Brand Name: 6.5MM LOW PROFILE HEX SCREW 30MM
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7179839
• Report Number: 0002249697-2018-00120
• Device Sequence Number: 19144797
• Product Code: LPH
• UDI-Device Identifier: 07613327345063
• UDI-Public: 07613327345063
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2022
• Device Catalogue Number: 7030-6530
• Device Lot Number: 95C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 76