MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD CON DIST STEM 16 X 195 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6276-7-116
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Reaction (2414); Inadequate Osseointegration (2646)
Date of Event	01/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
The sales rep confirmed that on (b)(6) 2017, the patient underwent a revision of a dupuy hip system due to metal-on-metal wear.The restoration modular stem that was implanted was too long and perforated the patient¿s femur.On (b)(6) 2017, the surgeon removed the restoration modular stem, cut it and re-implanted it back into the patient.Patient in less pain than the first operation.The only device replaced during this procedure was the ceramic head.
Additional Manufacturer Narrative
An event regarding the stem going through the femur (periprosthetic fracture) involving a restoration modular stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-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 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.
Event or Problem Description
The sales rep confirmed that on (b)(6) 2017, the patient underwent a revision of a dupuy hip system due to metal-on-metal wear.The restoration modular stem that was implanted was too long and perforated the patient¿s femur.On (b)(6) 2017, the surgeon removed the restoration modular stem, cut it and re-implanted it back into the patient.Patient in less pain than the first operation.The only device replaced during this procedure was the ceramic head.

• Brand Name: MOD CON DIST STEM 16 X 195 MM
• 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: 6297332
• Report Number: 0002249697-2017-00426
• Device Sequence Number: 19084719
• Product Code: LZO
• UDI-Device Identifier: 07613154058624
• UDI-Public: (01)07613154058624(11)151029(17)201031(10)CAXT60RG
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 10/31/2020
• Device Catalogue Number: 6276-7-116
• Device Lot Number: CAXT60RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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: 47 YR