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

Catalog Number	6265-5115
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/13/2019
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
Patient was at his account and crossed his legs and head disassociated from stem.Update (b)(6) 2019 wg: spoke to rep.A right hip x-ray from (b)(6) 2019, usage sheet, and explant picture were provided.Rep confirmed no further information will be available.
Event or Problem Description
Patient was at his account and crossed his legs and head disassociated from stem.Update 17/september/2019 wg: spoke to rep.A right hip x-ray from (b)(6) 2019, usage sheet, and explant picture were provided.Rep confirmed no further information will be available.
Additional Manufacturer Narrative
An event regarding disassociation is reported involving stem.The event is confirmed by review clinical review of x ray.Method & results: product evaluation and results - visual inspection of provided explant images are done and observed that: black material can be observed at stem upper side also blood and scratches can be observed at stem surface.Functional, dimensional and material analysis of device could not performed as no device is return for examination.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant rejected and stated that: x-ray provided confirms disassociation, need additional information; primary and revision operative reports, clinical and past medical history.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event was reported about disassociation involving stem.The event is confirmed by provided x ray.The exact cause of the event could not be determined because lack of information for example: further information such as 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 as no devices and/or insufficient information was received by stryker orthopaedics.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: 9177138
• Report Number: 0002249697-2019-03475
• Device Sequence Number: 3643202
• Product Code: LPH
• UDI-Device Identifier: 07613153074380
• UDI-Public: 07613153074380
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 08/31/2021
• Device Catalogue Number: 6265-5115
• Device Lot Number: 20117002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR