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

Catalog Number	1440-2010
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
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 (b)(4) other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Curved cup impactor broke during tap in the socket.Replacement was available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an impactor was reported.The event was confirmed through the material analysis report.Method & results: device evaluation and results: device evaluation was performed as part of the material analysis report (mar), date 02 feb 2018.{.}visual inspection: {.} the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The impactors were analyzed under a scanning electron microscope (sem) for further evaluation.{.}.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed due to a material integrity issue as there is evidence from the visual inspection that the device is damaged.Material analysis; a material analysis has been performed.The report concluded: {.} the impactors fractured due to a fatigue initiated crack at multiple locations.The cracks propagating and the final fracture occurred in an overload manner.Eds showed the impactors are consistent with 17-4 ph ss alloy.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 2 other similar events for the reported lot.Conclusion: the investigation concluded that {.} the impactors fractured due to a fatigue initiated crack at multiple locations.The cracks propagating and the final fracture occurred in an overload manner.Eds showed the impactors are consistent with 17-4 ph ss alloy.Based on the given information, 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.
Event or Problem Description
Curved cup impactor broke during tap in the socket.Replacement was available.

• Brand Name: CURVED CUP IMPACTOR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7144951
• Report Number: 0002249697-2017-03677
• Device Sequence Number: 11045921
• Product Code: LPH
• UDI-Device Identifier: 07613327010312
• UDI-Public: 07613327010312
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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 Catalogue Number: 1440-2010
• Device Lot Number: DC259274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/09/2018
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 62