MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
Revision of right total hip replacement due to titanium allergy.
Additional Manufacturer Narrative
Reported event: an event regarding allergy/reaction involving an accolade stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: the primary right tha was performed for a displaced intracapsular hip fracture.The lone post operative progress note states that the patient was recovering well.The revision operation was performed.On the revision operative report the reason for revision was noted to be "titanium allergy".During this procedure it was noted that the components were removed "atraumatically".A prophylactic wire was placed around the proximal femur prior to femoral removal.The revision components were cemented in place.The lone ap undated x-ray shows a pressfit tha in anatomic position without evidence of loosening or complication.No cement or prophylactic wire is evident on the image so it is reasonable to conclude this film was obtained prior to revision.Revision tha surgery is confirmed.Other than the operative report stating "titanium allergy" no other documentation ( progress notes, laboratory reports, intra-operative findings etc.) were available to substantiate this diagnosis.The root cause can not be established with this limited documentation.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: revision of right total hip replacement due to titanium allergy was reported.A review of the provided medical records by a clinical consultant stated the following comment: the primary right tha was performed for a displaced intracapsular hip fracture.The lone post operative progress note states that the patient was recovering well.The revision operation was performed.On the revision operative report the reason for revision was noted to be "titanium allergy".During this procedure it was noted that the components were removed "atraumatically".A prophylactic wire was placed around the proximal femur prior to femoral removal.The revision components were cemented in place.The lone ap undated x-ray shows a pressfit tha in anatomic position without evidence of loosening or complication.No cement or prophylactic wire is evident on the image so it is reasonable to conclude this film was obtained prior to revision.Revision tha surgery is confirmed.Other than the operative report stating "titanium allergy" no other documentation ( progress notes, laboratory reports, intra-operative findings etc.) were available to substantiate this diagnosis.The root cause can not be established with this limited documentation.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
Revision of right total hip replacement due to titanium allergy.

• Brand Name: SIZE 6 ACCOLADE II 132 DEG
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12860358
• Report Number: 0002249697-2021-01952
• Device Sequence Number: 14620625
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 11/30/2023
• Device Model Number: 6720-0635
• Device Catalogue Number: 6720-0635
• Device Lot Number: 688770007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 88 KG