MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK CURVED CUP IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1440-2010
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
Primary procedure, right hip.It was reported that the impactor bolt became stuck in the shell, and that the impactor sheared off where the handle meets the curved part of the impactor.All devices (including the shell) were removed from the patient and another shell was implanted.Surgery was completed successfully with a delay of approximately 2 minutes.Rep may be able to provide some additional patient information, otherwise confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a curved cup impactor was reported.The event was confirmed through the material analysis evaluation of the returned device.Method & results: device evaluation and results: material evaluation was completed and indicated the following comments: the curved cup impactor was returned fractured, the device was sectioned to aid in the analysis.The device was evaluated with a scanning electron microscope (sem).The observed mixed mechanism morphology is consistent with an overload fracture.Energy dispersive spectroscopy (eds) showed that the material is consistent with a 17-4ph alloy (fe-cr-ni-cu) which is consistent with the drawing.Hardness was evaluated per astm e18, and the average hardness of 42hrc meets the drawing requirement of 40hrc minimum.  based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been four other similar events for the reported lot.Conclusion: the investigation concluded that the fracture is consistent with an overload fracture.No identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CURVED CUP IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• MDR Report Key: 10355366
• Report Number: 0002249697-2020-01585
• Device Sequence Number: 3624345
• Product Code: LPH
• UDI-Device Identifier: 07613327010312
• UDI-Public: 07613327010312
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 12/31/2021
• Device Model Number: 1440-2010
• Device Catalogue Number: 1440-2010
• Device Lot Number: DC259274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/05/2020
• 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