MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #4 RIGHT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-5114
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Implant broach was flush to the neck resection, and sat proud by at least 4mm.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a citation stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: rejected for medical review: provided undated x-rays do not confirm the reported event.Need operative reports, clinical/office notes, histopathology reports, serial x-rays.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 return of the device, operative reports, clinical/office notes, histopathology reports, serial x-rays and examination of the explanted components 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.
Event or Problem Description
Implant broach was flush to the neck resection, and sat proud by at least 4mm.

• Brand Name: CITATION TMZF HA STEM #4 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: 8148708
• Report Number: 0002249697-2018-03967
• Device Sequence Number: 2027401
• Product Code: LPH
• UDI-Device Identifier: 07613153074373
• UDI-Public: 07613153074373
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 02/28/2023
• Device Catalogue Number: 6265-5114
• Device Lot Number: 60499902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 04/03/2019
• 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: 71 YR