MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28X46-49MM 10 DEG INS DURAT; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6299-6-469
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient had a pelvic tumor causing osteolysis and loosening of the implant.Therefore plan was to remove cup and liner and change head.
Additional Manufacturer Narrative
An event regarding osteolysis involving a pca insert was reported.The event was confirmed by the provided x-ray.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided x-ray by a clinical consultant indicated: x-ray shows vertical acetabulum and osteolysis.No confirmation of tumor, need operative reports and additional serial x-rays.-product history review: indicates all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: a review of the provided x-ray by a clinical consultant indicated: x-ray shows vertical acetabulum and osteolysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, serial x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a pelvic tumor causing osteolysis and loosening of the implant.Therefore plan was to remove cup and liner and change head.

• Brand Name: 28X46-49MM 10 DEG INS DURAT
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7798007
• Report Number: 0002249697-2018-02582
• Device Sequence Number: 11278057
• Product Code: LPH
• UDI-Device Identifier: 04546540268259
• UDI-Public: 04546540268259
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 09/30/2018
• Device Catalogue Number: 6299-6-469
• Device Lot Number: 45003401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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
• Patient Weight: 60