MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK MOD CON DIST STEM 16 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-016
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	06/08/2020
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.
Event or Problem Description
It was reported that the patient's left hip was revised due to instability.Surgeon reported his suspicion that the proximal cone body was probably not fully seated during the primary implantation.The proximal cone body, biolox ceramic head, and 36d 0° insert were revised to a proximal cone body, lfit v40 head, size d constrained insert, and a dall-miles grip plate with cables.Rep provided usage sheets for the primary and revision surgeries, pictures of the explants, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event an event regarding malposition involving a restoration modular body was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:the photos provided show a significant amount of blood on the the explanted modular body.There is also some evidence of bone ingrowth on the ha coated portion of the device.There is nothing else remarkable to note.-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.H3 other text : device not available.
Event or Problem Description
It was reported that the patient's left hip was revised due to instability.Surgeon reported his suspicion that the proximal cone body was probably not fully seated during the primary implantation.The proximal cone body, biolox ceramic head, and 36d 0° insert were revised to a proximal cone body, lfit v40 head, size d constrained insert, and a dall-miles grip plate with cables.Rep provided usage sheets for the primary and revision surgeries, pictures of the explants, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: MOD CON DIST STEM 16 X 155 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• MDR Report Key: 10194103
• Report Number: 0002249697-2020-01296
• Device Sequence Number: 3016667
• Product Code: LPH
• UDI-Device Identifier: 04546540643742
• UDI-Public: 04546540643742
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/21/2020

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: 09/30/2021
• Device Model Number: 6276-7-016
• Device Catalogue Number: 6276-7-016
• Device Lot Number: CAXV33AA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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 Age: 64 YR
• Patient Weight: 68