MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 15 X 155 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-7-015
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported by scrub technician that revision surgery performed due to patient feel pain in the hip for a while after having hip reconstruction surgery long time ago, after x-ray, x-ray film revealed that hip component was loose.(stryker staff awareness date is the revision surgery as exact primary device type is unknown).
Event or Problem Description
It was reported by scrub technician that revision surgery performed due to patient feel pain in the hip for a while after having hip reconstruction surgery long time ago, after x-ray, x-ray film revealed that hip component was loose.(stryker staff awareness date is the revision surgery as exact primary device type is unknown).
Additional Manufacturer Narrative
Updated the manufacturing and expiration date.Reported event: an event regarding loosening involving a restoration modular stem 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: photos show an explanted device with nothing remarkable to note.Clinician review: 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: MOD CON DIST STEM 15 X 155 MM
• 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: 10725267
• Report Number: 0002249697-2020-02222
• Device Sequence Number: 11291101
• Product Code: LPH
• UDI-Device Identifier: 04546540643735
• UDI-Public: 04546540643735
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 05/31/2024
• Device Model Number: 6276-7-015
• Device Catalogue Number: 6276-7-015
• Device Lot Number: CAXX531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: 69 YR