MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS EXTENSION PIECE 80MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64956080
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/03/2018
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 relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
In reporting a revision of patient's left knee on (b)(6) 2018, rep was made aware of a previous revision on (b)(6) 2016 (rep was not present for procedure).In that procedure, an 80mm extension piece was implanted.On (b)(6) 2018, a 100mm extension piece was explanted.Rep is unaware of when the 80mm extension piece was revised.This event is for revision 1 which took place some time between (b)(6) 2016 and (b)(6) 2018.
Additional Manufacturer Narrative
An event regarding revision of an 80 mm gmrs extension piece to a 100 mm gmrs extension piece was identified.The event was confirmed through x-ray review.Conclusions: review of x-rays provided by a clinician confirm the revision surgery from an 80 mm extension piece to a 100 mm extension piece has taken place sometime between october 11, 2016, and november 30, 2017.The clinician indicates "even though no details were provided for this surgery other than exchange of 80-mm to 100-mm extension piece, the type of procedure in a growing skeleton makes clear that this exchange was performed for the sole purpose to keep the leg lengths¿ of this patient equal.".While it is highly likely that this is the case, without bilateral x-rays, medical records, operative reports and follow-up notes this cannot be confirmed as the root cause for the revision surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
In reporting a revision of patient's left knee on (b)(6) 2018, rep was made aware of a previous revision on (b)(6) 2016 (rep was not present for procedure).In that procedure, an 80mm extension piece was implanted.On (b)(6) 2018, a 100mm extension piece was explanted.Rep is unaware of when the 80mm extension piece was revised.This event is for revision 1 which took place some time between 09/26/2016 and 01/03/2018.

• Brand Name: GMRS EXTENSION PIECE 80MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7222700
• Report Number: 0002249697-2018-00251
• Device Sequence Number: 11324935
• Product Code: KRO
• UDI-Device Identifier: 07613327049220
• UDI-Public: 07613327049220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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: 01/31/2021
• Device Catalogue Number: 64956080
• Device Lot Number: ASK6M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/13/2018
• 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: 16 YR