MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #5 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6265-5115
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
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.Device not returned.
Event or Problem Description
As reported: "removed stem, liner and head from patient replacing with stryker restoration stem/ cone body, cables and mdm implants.No other and no more information available from hospital." rep confirmed that the femoral head disassociated from the stem.
Event or Problem Description
As reported: "removed stem, liner and head from patient replacing with stryker restoration stem/ cone body, cables and mdm implants.No other and no more information available from hospital." rep confirmed that the femoral head disassociated from the stem.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and damage involving a citation stem was reported.The disassociation event was not confirmed; the damage event was confirmed via photographs.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the photo of the stem shows blood throughout the part and trunnion damage.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CITATION TMZF HA STEM #5 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: 9711670
• Report Number: 0002249697-2020-00309
• Device Sequence Number: 16635276
• Product Code: LPH
• UDI-Device Identifier: 07613153074380
• UDI-Public: 07613153074380
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2010
• Device Model Number: 6265-5115
• Device Catalogue Number: 6265-5115
• Device Lot Number: 11135904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 94