MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-121; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-121
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Osteolysis (2377)
Date of Event	12/17/2019
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 similar 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.The following devices were also listed in this report: mod con dist stem 14 x 155 mm; cat# 6276-7-014; lot# caxn314, v40 cocr lfit head 36mm/0; cat# 6260-9-136; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "painful total left hip." the patient's restoration modular stem construct and femoral head were revised to competitor devices.
Event or Problem Description
As reported: "painful total left hip." the patient's restoration modular stem construct and femoral head were revised to competitor devices.Update as per medical review, 'on (b)(6) 2019 a revision left total hip arthroplasty was performed for a post-operative diagnosis of ¿osteolysis left proximal femur with pain.
Additional Manufacturer Narrative
Reported event: an event regarding revision and pain involving a restoration modular body was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: -on (b)(6) 2019 an mri of the left hip report notes, ¿1.Osteolysis adjacent to ¿ acetabular ¿ and femoral components; 2.Increased volume ¿ hip joint effusion; 3.¿ tear of gluteus minimus tendon ¿¿ -on (b)(6) 2019 a revision left total hip arthroplasty was performed for a post-operative diagnosis of ¿osteolysis left proximal femur with pain¿.-no clinical or past medical history, no operative report for the primary or first revision left total hip arthroplasty, no imaging studies, and no follow-up until (b)(6) 2019 are noted.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: 21MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-121
• 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: 9588674
• Report Number: 0002249697-2020-00102
• Device Sequence Number: 11597455
• Product Code: LPH
• UDI-Device Identifier: 04546540641144
• UDI-Public: 04546540641144
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 10/31/2018
• Device Model Number: 6276-1-121
• Device Catalogue Number: 6276-1-121
• Device Lot Number: 45287502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: 76 YR
• Patient Weight: 109