MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #6 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-5116
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
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.When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
Surgeon implanted the femoral stem into the canal and noticed there were some significant scratches on the trunnion.Due to the use of the use of a ceramic head he opted to remove the stem and implant a new one.Surgeon says that it was scratched out of the package however the stem was implanted before the scratches were noticed so there is no way of knowing.
Event or Problem Description
Surgeon implanted the femoral stem into the canal and noticed there were some significant scratches on the trunnion.Due to the use of the use of a ceramic head he opted to remove the stem and implant a new one.Surgeon says that it was scratched out of the package however the stem was implanted before the scratches were noticed so there is no way of knowing.
Additional Manufacturer Narrative
An event regarding damage involving a citation stem was reported.The event was confirmed by device images.Method & results: product evaluation and results: damage observed on the stem consistent with attempted implantation/explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation confirmed the reported event of damage on the implant however, the exact root cause could not be determined.Further assessment beyond an examination with an engineer could not be performed as the damage visible on the trunnion is consistent with implantation and explantation damage.Further information is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CITATION TMZF HA STEM #6 RIGHT
• 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: 8466807
• Report Number: 0002249697-2019-01480
• Device Sequence Number: 16835644
• Product Code: LPH
• UDI-Device Identifier: 07613153074397
• UDI-Public: 07613153074397
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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): 05/16/2019

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: 11/30/2020
• Device Catalogue Number: 6265-5116
• Device Lot Number: 52420502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: 64 YR