MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-125
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening (slipped (rotated) 180°) involving a restoration modular body was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not available.
Event or Problem Description
It was reported that patient's left hip was revised because the proximal body of the stem slipped (rotated) 180° due to the lack of a locking screw.Rep did not report dislocation or disassociation.A 25 +10 proximal body, 28 +8 lfit v40 head, 42e adm insert and 42e mdm liner were explanted and a girdlestone procedure was performed.Rep reported that x-rays, medical records, and further information are not available.

• Brand Name: 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125
• 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: 8183212
• Report Number: 0002249697-2018-04088
• Device Sequence Number: 2025040
• Product Code: LPH
• UDI-Device Identifier: 04546540641168
• UDI-Public: 04546540641168
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 12/19/2018

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: 12/31/2022
• Device Catalogue Number: 6276-1-125
• Device Lot Number: 61904301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/19/2018
• 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: 45 YR