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

Catalog Number	1236-2-244
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/23/2018
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 similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's hip (side not reported) was revised after a review of x-rays showed the insert selected and implanted the day previously was not the correct size for the procedure.
Additional Manufacturer Narrative
An event regarding an incorrect selection involving an adm liner was reported.The event was confirmed following a review by a clinical consultant.Method & results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: patient underwent a revision tha on (b)(6) 2018, review of the post operative x-ray revealed an incorrectly sized implant had been placed necessitating revision.This was performed the following day.Single undated ap and lateral x-rays of a revision tha show a femoral head that does not appear to be seated within the mobile bearing acetabular insert.Device history review: indicated all devices accepted into final stock with no relevant discrepancies.Complaint history review: there has been no other similar events for the lot referenced.Conclusions: a review of the provided x-rays by a clinical consultant concluded: "the primary harm involved is placement of incorrect size tha implant there is no evidence for defect in the implants or their manufacture." if further information becomes available and/or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that patient's hip (side not reported) was revised after a review of x-rays showed the insert selected and implanted the day previously was not the correct size for the procedure.

• Brand Name: RESTORATION ADM X3 INS
• 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
• MDR Report Key: 7442544
• Report Number: 0002249697-2018-01163
• Device Sequence Number: 1006589
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 01/31/2022
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 347107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 45 YR
• Patient Weight: 97