MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 27MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-127; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6276-1-127
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/12/2018
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.Not returned to the manufacturer.
Event or Problem Description
It was reported that patient's right hip was revised due to disassociation of the head from the stem.Intra-operatively, the ring on the competitor constrained liner was found broken.No trauma was reported to the rep.The proximal stem body and metal head were revised to a stryker proximal stem body, femoral head, and liner.
Additional Manufacturer Narrative
An event regarding disassociation involving a restoration modular body was reported.The event was confirmed based on evaluation of the returned devices.Method & results: -product evaluation and results: material analysis concluded: damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the cyclic contact between the head taper and stem trunnion after the loss of their taper lock.Eds showed the head was consistent with astm f1537 alloy, the cone body and the adhered debris from the head were consistent with a ti-6al-4v alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray confirms the disassociated head and stem.Need patient demographics, operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components.-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 were no other similar events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including patient demographics, operative reports, clinical reports, histopathology reports, office notes, serial x-rays are needed to fully investigate the event.
Event or Problem Description
It was reported that patient's right hip was revised due to disassociation of the head from the stem.Intra-operatively, the ring on the competitor constrained liner was found broken.No trauma was reported to the rep.The proximal stem body and metal head were revised to a stryker proximal stem body, femoral head, and liner.

• Brand Name: 27MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-127
• 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: 8055768
• Report Number: 0002249697-2018-03673
• Device Sequence Number: 19312988
• Product Code: LPH
• UDI-Device Identifier: 04546540641175
• UDI-Public: 04546540641175
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 12/30/2022
• Device Catalogue Number: 6276-1-127
• Device Lot Number: 62097202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 03/15/2019
• 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: 83 YR