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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/24/2019
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.Device not returned.
Event or Problem Description
As reported: "cup, head, liners removed due to metallosis caused by malpositioned implants resulting in impingement".
Additional Manufacturer Narrative
An event regarding metallosis caused by malpositioned implants resulting in impingement was reported.Conclusion based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.The adm liner component is a polyethylene component located within the mdm liner, the reported event is regarding metallosis caused by malpositioned implants resulting in impingement, the polyethylene adm liner component would not have been in a position to generate metal debris to cause the reported metallosis.The device also does not interface with the patients bone, it is fixed within the mdm liner and hence, could not be malpositioned.A full investigation is completed on bone interfacing components - trident tritanium shell and unknown stem which may have been malpositioned resulting in impingement and also the metal mdm liner (pr 2071533) which may have impinged with the stem resulting in metallic fretting debris within the same pi.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
As reported: "cup, head, liners removed due to metallosis caused by malpositioned implants resulting in impingement".

• 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: 8627319
• Report Number: 0002249697-2019-02002
• Device Sequence Number: 11327027
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/24/2019

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: 09/30/2020
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 282099
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: 55 YR