MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 10 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1601-10127
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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.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
Primary procedure, right hip.It was reported that when the secur-fit advanced stem was opened, the ha coating at the proximal end of the stem seemed too thick.Another stem was opened and used to complete the surgery successfully with no delay.Rep was present for and witnessed the procedure.Rep provided a picture of the device (which is allegedly available for return) and the sales order for the case and 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 when the secur-fit advanced stem was opened, the ha coating at the proximal end of the stem seemed too thick.Another stem was opened and used to complete the surgery successfully with no delay.Rep was present for and witnessed the procedure.Rep provided a picture of the device (which is allegedly available for return) and the sales order for the case and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event involving a securfit stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device noted the following: device was returned in unused condition.The ha coating appeared thicker than usual.No other remarkable observations were noted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the global quality & operations (gqo) team reviewed the event and stated: in conclusion, while the surgeon perceived the normalization lines to not be as defined as they are accustomed to, it was confirmed through the dhr review, and process review that there are proper process controls in place to determine that this product did meet all design requirements and would have functioned as intended.

• Brand Name: 127 SIZE 10 SECUR-FIT ADVANCED STEM
• 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: 11276741
• Report Number: 0002249697-2021-00211
• Device Sequence Number: 4831228
• Product Code: LPH
• UDI-Device Identifier: 07613327021356
• UDI-Public: 07613327021356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/01/2021

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: 10/31/2024
• Device Model Number: 1601-10127
• Device Catalogue Number: 1601-10127
• Device Lot Number: 393ARD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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