MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0130
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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
Physician used broaches as usual, starting from size 0 and stopped when reached size 1.Confirmed by a surgeon, the physician chooses a size 1 for the prosthesis.The prosthesis that was opened, size 1, did not fit the femur canal.But surgeon proceed with the surgery and closed the incision.When finished, a surgeon measured the leg, and found that the leg was not the same length (about 1.5cm longer).To solve this the surgeon needed to reopen the surgery, which was 2.5 hours later because the surgeon needed to resterilize a set.The surgeon removed the stem and compared the prosthesis size with the broach.The physician stated that the prosthesis size 1 that was opened earlier was actually a size 2.Surgeon re-rasped a femur using a size 2 broach.The surgery was completed successfully with the same prosthesis.Patient was sent to icu after the surgery because of 9 hours of operation under a general anesthesia.
Additional Manufacturer Narrative
An event regarding user error involving an accolade tmzf stem used in conjunction with accolade ii bone preparation instruments was reported.The event was confirmed based on examination of the images provided which indicates the use of accolade ii rasp instrument with an accolade tmzf stem.Method & results: -device evaluation and results: the device was not returned however images of the explanted device were provided.There was blood noted on the stem, the device was otherwise unremarkable.-medical records received and evaluation: not performed due to the nature of the reported event.This event is considered an off label application.-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 accolade tmzf surgical protocol, acc-sp-1 includes details relating to the selection of the instrumentation when implanting accolade tmzf stems.All instrumentation to be used, including the selection of raps is included in the protocol.There is no indication in the protocol that suggests using accolade ii instrumentation when implanting accolade tmzf stems.This event is therefore considered an off label application.No further investigation is required at this time.If further relevant information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Physician used broaches as usual, starting from size 0 and stopped when reached size 1.Confirmed by a surgeon, the physician chooses a size 1 for the prosthesis.The prosthesis that was opened, size 1, did not fit the femur canal.But surgeon proceed with the surgery and closed the incision.When finished, a surgeon measured the leg, and found that the leg was not the same length (about 1.5cm longer).To solve this the surgeon needed to reopen the surgery, which was 2.5 hours later because the surgeon needed to resterilize a set.The surgeon removed the stem and compared the prosthesis size with the broach.The physician stated that the prosthesis size 1 that was opened earlier was actually a size 2.Surgeon re-rasped a femur using a size 2 broach.The surgery was completed successfully with the same prosthesis.Patient was sent to icu after the surgery because of 9 hours of operation under a general anesthesia.

• Brand Name: ACCOLADE TMZF HIP STEM #1
• 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: 6759074
• Report Number: 0002249697-2017-02351
• Device Sequence Number: 1967251
• Product Code: LPH
• UDI-Device Identifier: 04546540510532
• UDI-Public: 04546540510532
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: 09/27/2021
• Device Catalogue Number: 6020-0130
• Device Lot Number: 55852502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 10/19/2017
• 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: 70 YR