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 Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/14/2019
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.
Event or Problem Description
It was reported that the patient's right hip was revised.Pre-revision patient complaint included hearing a popping sound.Intra-operatively, the following were noted: trunnion wear, trunnion broke off the stem, grayish black tissue, wear of the liner's rim due to impingement of the stem on the liner.The shell had no allegations against it and was not revised.Patient was revised to a restoration modular stem construct with a ceramic head and new liner.Rep provided intra- op photos and an explant picture and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding trunnion wear and crack/fracture resulting in inflammatory response and impingement of the stem against the liner involving a citation stem was reported.Based on the images provided a fracture surface can be observed on the worn trunnion of the device as well as blackened tissue in the joint.The reported impingement however could not be confirmed based on the provided information.Method & results product evaluation and results: the reported device was not returned however three photographs were provided for review.Two of the photographs were taken intra-operatively, based on the first image, a fracture surface can be identified on the stem trunnion which is visibly worn.The second image shows the opened wound with what appears to be some darkened tissue/liquid.The third image provided, is a grey/black item placed on a surgical gauze, it cannot be confirmed if the item is blackened tissue, or the fractured section of the stem trunnion.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: while the wear and fracture of the trunnion as well as the inflammatory response (blackened tissue) can be confirmed based on the images provided, the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return and evaluation, 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patients right hip was revised.Pre-revision patient complaint included hearing a popping sound.Intra-operatively, the following were noted: trunnion wear, trunnion broke off the stem, grayish black tissue, wear of the liners rim due to impingement of the stem on the liner.The shell had no allegations against it and was not revised.Patient was revised to a restoration modular stem construct with a ceramic head and new liner.Rep provided intra- op photos and an explant picture and reported that no further information will be available.

• 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: 9295774
• Report Number: 0002249697-2019-03717
• Device Sequence Number: 11352898
• Product Code: LPH
• UDI-Device Identifier: 07613153074380
• UDI-Public: 07613153074380
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 07/30/2010
• Device Catalogue Number: 6265-5115
• Device Lot Number: 13577801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 71 YR
• Patient Weight: 97