MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	1236-2-850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2022
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: restoration (tm) adm.Cup w/ha; cat# 1235-2-501; lot# g3087476, delta v-40 ceramic head 28/0; cat# 6570-0-128; lot# 33444301, accolade (127 deg) size 3.5 accolade (127 deg) size 3.5; cat# 6021-3535; lot# 36017801.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following was reported: subject 70-02-004r completed the 8-year visit by mail for the 70-restoration adm x3 study.The subject completed the follow-up questionnaire.The subject answered "yes" for hip pain with the comment "dull ache much of the time".The subject answered "no" for satisfaction for study hip replacement with the comment "i wish it didn't ache".The subject answered "no" with no additional comment for the have you had surgery on your study hip and has your hip dislocated since your last study visit.X-rays were not completed as this was a remote visit.The last x-rays collected were from the 7-year visit.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving an adm liner was reported.The event was not confirmed, method & results: device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: the root cause of patient's pain and dissatisfaction cannot be known at this time with the information given.Since there is no description of where the pain is, characteristics of the pain, or any other specific information.The root cause of the pain and dissatisfaction cannot be determined with the information supplied.Based upon the information given and the radiographs supplied, i would not assign any cause of the patient's problem to the implant at this time.Device history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other similar event for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had a right total hip arthroplasty since i was able to see the seven year follow-up x-ray.The root cause of patient's pain and dissatisfaction cannot be known at this time with the information given.Since there is no description of where the pain is, characteristics of the pain, or any other specific information.The root cause of the pain and dissatisfaction cannot be determined with the information supplied.Based upon the information given and the radiographs supplied, i would not assign any cause of the patient's problem to the implant at this time.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: subject 70-02-004r completed the 8-year visit by mail for the 70-restoration adm x3 study.The subject completed the follow-up questionnaire.The subject answered "yes" for hip pain with the comment "dull ache much of the time".The subject answered "no" for satisfaction for study hip replacement with the comment "i wish it didn't ache".The subject answered "no" with no additional comment for the have you had surgery on your study hip and has your hip dislocated since your last study visit.X-rays were not completed as this was a remote visit.The last x-rays collected were from the 7-year visit.

• Brand Name: RESTORATION ADM X3 INS 28/50
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15822435
• Report Number: 0002249697-2022-01659
• Device Sequence Number: 6004690
• Product Code: MEH
• UDI-Device Identifier: 04546540638984
• UDI-Public: 04546540638984
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 06/30/2016
• Device Model Number: 1236-2-850
• Device Catalogue Number: 1236-2-850
• Device Lot Number: 37165401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2011
• 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: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White