MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	1236-2-848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: size 5 accolade ii 127 deg; cat# 6721-0535 ; lot# 51193301 delta v-40 ceramic head 28/0; cat# 6570-0-128 ; lot# 51232504 primary trit hemi cluster hole cup 56mm; cat# 502-03-56e ; lot# yj2jx4 6.5 cancellous bone screw 30mm; cat# 2030-6530-1; lot# l17vre modular dual mobility insert; cat#626-00-42e; lot# 51085602 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Pt.Reported via phone that; they need some information on these products, on these implants which was recalled.I just had a revision surgery.2016 had discomfort, and pain in the hip which was diagnosed as a pinched nerve and received cortisone shots for it.Scarred tissue was noticed during revision.
Additional Manufacturer Narrative
Reported event: an event regarding patient factors (lumbar degenerative disease) involving an adm liner was reported.The event was confirmed via 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 information by a clinical consultant indicated: documents reviewed demonstrate that the patient had an uneventful tha (b)(6) 2015.Recovered reasonably well but had ongoing lateral and anterior thigh pain.Her surgeon pursued this with both an infectious and mechanical work up which proved to be negative.She was referred to the spine team and found to have severe lumbar degenerative facet disease.She received a series of nerve root ablations with modicum of relief.No documentation of an exploratory arthrotomy was provided.Ongoing anterior lateral thigh pain following tha is confirmed.The root cause of this pain was determined to ne related to lumbar degenerative disease.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.Conclusions: no device-related failure modes were reported and the implants were revised during this procedure.Documents reviewed demonstrate that the patient had an uneventful tha (b)(6) 2015.Recovered reasonably well but had ongoing lateral and anterior thigh pain.Her surgeon pursued this with both an infectious and mechanical work up which proved to be negative.She was referred to the spine team and found to have severe lumbar degenerative facet disease.She received a series of nerve root ablations with modicum of relief.No documentation of an exploratory arthrotomy was provided.Ongoing anterior lateral thigh pain following tha is confirmed.The root cause of this pain was determined to ne related to lumbar degenerative disease.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.
Event or Problem Description
Pt.Reported via phone that; they need some information on these products, on these implants which was recalled.I just had a revision surgery.2016 had discomfort, and pain in the hip which was diagnosed as a pinched nerve and received cortisone shots for it.Scarred tissue was noticed during revision.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 19992131
• Report Number: 0002249697-2024-01127
• Device Sequence Number: 8585945
• Product Code: LZO
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 09/30/2019
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 49240401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2014
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 232 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American