MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-50D
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.It was reported that the magnetic bolt could not thread into the shell.A second magnetic bolt, and then an older da impactor, were tried with the same result.At the back table, when the devices were separated, a circular piece of metal fell onto the table.The surgeon reamed to a larger size and implanted a larger shell using one of the first two magnetic bolts, which operated as intended.Surgery was completed successfully with a delay of approximately 8 minutes.The device is allegedly available for return and the rep can provide the primary usage sheet, but no further information will be released by the hospital or surgeon as no patient harm was perceived.
Additional Manufacturer Narrative
An even regarding an assembly whereby the magnetic bolt could not thread into the shell was reported.The event was confirmed through material analysis evaluation of the returned device.Method & results: device evaluation and results: the shell was returned for evaluation.A scratch was observed on the distal surface of the shell.Damage was also observed on the internal threads of the shell.Material evaluation was completed and indicated the following comments: biological material was observed on the proximal surface of the shell.Damage was observed on the internal threads consistent with contact against a hard object.Damage consistent with contact against a hard object was also observed on the distal surface.Energy dispersive spectroscopy showed the material is consistent with an astm f136 alloy, which is consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: not performed as no medical records were received for review.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the shell was returned for evaluation.A scratch was observed on the distal surface of the shell.Damage was also observed on the internal threads of the shell.Material evaluation was completed and indicated the following comments: biological material was observed on the proximal surface of the shell.Damage was observed on the internal threads consistent with contact against a hard object.Damage consistent with contact against a hard object was also observed on the distal surface.Energy dispersive spectroscopy showed the material is consistent with an astm f136 alloy, which is consistent with the drawing.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, right hip.It was reported that the magnetic bolt could not thread into the shell.A second magnetic bolt, and then an older da impactor, were tried with the same result.At the back table, when the devices were separated, a circular piece of metal fell onto the table.The surgeon reamed to a larger size and implanted a larger shell using one of the first two magnetic bolts, which operated as intended.Surgery was completed successfully with a delay of approximately 8 minutes.The device is allegedly available for return and the rep can provide the primary usage sheet, but no further information will be released by the hospital or surgeon as no patient harm was perceived.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• 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: 9347280
• Report Number: 0002249697-2019-03821
• Device Sequence Number: 2739659
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• 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): 02/24/2020

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: 07/31/2023
• Device Model Number: 502-03-50D
• Device Catalogue Number: 502-03-50D
• Device Lot Number: 626PWA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/24/2020
• 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: 70 YR