MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-019
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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.
Event or Problem Description
It was reported that patient's left hip was revised due to dislocation.The head dislocated from the liner as a result of the proximal body disassociating from the plasma stem and pulling the head out of the liner.Patient had been performing a non-compliant activity (bending over) when dislocation/ disassociation occurred.Surgeon reported he was unsure if the disassociation occurred because of surgeon error or device failure of the locking mechanism.Rep noted that during implantation, surgeon did not use torque wrench, but applied force by free-hand tightening the locking mechanism.A biolox ceramic head and restoration proximal body were revised to the same catalog numbers of different lot codes as the surgeon decided not to re-implant the revised devices.
Additional Manufacturer Narrative
An event regarding disassociation and loosening involving a restoration modular body was reported.The event was not confirmed.Method & results: -product evaluation and results: the material analysis report concluded the following: damages were observed on the cone body, consistent with the explantation process and services of the devices in situ.A circumferential metal transfer ring was observed at the proximal end of the taper, indicating proper seating between the head taper and stem trunnion.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were returned for review.-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 events for the lot provided.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 as insufficient information was received by stryker orthopaedics.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient's left hip was revised due to dislocation.The head dislocated from the liner as a result of the proximal body disassociating from the plasma stem and pulling the head out of the liner.Patient had been performing a non-compliant activity (bending over) when dislocation/ disassociation occurred.Surgeon reported he was unsure if the disassociation occurred because of surgeon error or device failure of the locking mechanism.Rep noted that during implantation, surgeon did not use torque wrench, but applied force by free-hand tightening the locking mechanism.A biolox ceramic head and restoration proximal body were revised to the same catalog numbers of different lot codes as the surgeon decided not to re-implant the revised devices.

• Brand Name: 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019
• 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: 8146438
• Report Number: 0002249697-2018-03947
• Device Sequence Number: 16634495
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 65424702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/27/2019
• 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; Other; Required Intervention
• Patient Age: 42 YR