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

Model Number	1440-2011
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a hip procedure, the bolt cold welded into the shell.
Event or Problem Description
It was reported that during a hip procedure, the bolt cold welded into the shell.
Additional Manufacturer Narrative
An event regarding a disassembly issue during implantation involving a tritanium shell and an impactor bolt was reported.The event was confirmed based on evaluation of the returned devices.Method & results: device evaluation and results: the shell was returned with the impactor bolt still assembled to it.Visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with attempted implantation was observed on the female threads of the shell and the male threads of the impactor bolt.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Material evaluation was completed and indicated the following comments: damage consistent with attempted implantation was observed on the female threads of the shell and the male threads of the impactor bolt.Energy dispersive spectroscopy and x-ray florescence spectroscopy were was performed on the shell (astm f136) and bolt (17-4 ph), respectively.The analysis showed that the devices were consistent with their respective drawings.Hardness testing was performed per astm e18 on the threaded stud of the bolt which had a hardness of 47hrc meeting the drawing requirement of 40hrc minimum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.  complaint history review: there have been no other similar events for the reported lot.Conclusion: the reported event was confirmed based on evaluation of the returned devices.The shell was returned with the impactor bolt still assembled to it.Damage consistent with attempted implantation was observed on the female threads of the shell and the male threads of the impactor bolt.Material evaluation was completed and indicated the following comments: energy dispersive spectroscopy and x-ray florescence spectroscopy were was performed on the shell (astm f136) and bolt (17-4 ph), respectively.The analysis showed that the devices were consistent with their respective drawings.Hardness testing was performed per astm e18 on the threaded stud of the bolt which had a hardness of 47hrc meeting the drawing requirement of 40hrc minimum.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.If further information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CUP IMPACTOR BOLT
• 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: 9408820
• Report Number: 0002249697-2019-03937
• Device Sequence Number: 2966442
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: 07/31/2022
• Device Model Number: 1440-2011
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERDVD7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/14/2020
• 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