MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 11MM PRESS FIT FLUTED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6495-5-011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding a disassembly issue involving a gmrs stem 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: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports 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.Not available.
Event or Problem Description
It was reported that, for a patient who was operated several times by the same surgeon, the last surgery was the second failed attempt to exchange the growing piece of his gmrs implant (hmrs/gmrs spigot separator).A longer growing piece is needed, growing piece the patient currently has failed/lost it¿s ability to keep it¿s full length.It is suspected that separation of the stem/growing piece spigot failed because of cold fusion.The patient ((b)(6) year old boy) has 6cm difference in leg length, the original growing component is set to it¿s maximum length but as it¿s collapsed once the patient¿s parents lost their trust in the device.It is not clear why/how the device lost it¿s internal blockage, but the surgeon found it collapsed ( in the shortest position instead of the last set elongation ) in the operation when they wanted to do the last adjustment ( the last 5mm ) before changing to the longer piece.After they went through the elongation steps again - 2-3 small surgeries - they reached full length again, the device showed no signs of failure/instability.

• Brand Name: 11MM PRESS FIT FLUTED STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8386838
• Report Number: 0002249697-2019-01246
• Device Sequence Number: 13516184
• Product Code: LZO
• UDI-Device Identifier: 07613327033489
• UDI-Public: 07613327033489
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K031217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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 Catalogue Number: 6495-5-011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/04/2019
• 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: Other
• Patient Age: 14 YR