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

Catalog Number	6276-1-127
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a restoration modular body was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review : not performed as the device lot details are unknown.Complaint history review : not performed as the device lot details are unknown.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Operative side: right.The proximal cone body implant was not fully seated from the (b)(6) 2018 surgery.Doctor removed the loose cone body and prepared for a replacement cone body.Removed implants: cone body, biolox head.Rep confirmed that the distal stem was not actually revised and remains implanted.
Event or Problem Description
Operative side: right.The proximal cone body implant was not fully seated from the (b)(6) /2018 surgery.Doctor removed the loose cone body and prepared for a replacement cone body.Removed implants: 1.Cone body, 2.Biolox head.Rep confirmed that the distal stem was not actually revised and remains implanted.
Additional Manufacturer Narrative
Additional information: historical data analysis an event regarding seating/locking issues involving a restoration modular body was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: 27MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-127
• 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: 7864712
• Report Number: 0002249697-2018-02827
• Device Sequence Number: 1720260
• Product Code: LPH
• UDI-Device Identifier: 04546540641175
• UDI-Public: 04546540641175
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 05/31/2021
• Device Catalogue Number: 6276-1-127
• Device Lot Number: 55109501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 77 YR
• Patient Weight: 100