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 Code	Pain (1994)
Date of Event	12/17/2018
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.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: primary tritanium hemi cluster hole cup 50 mm; cat# 502-03-50d; lot# mkmen5, modular dual mobility insert; cat# 626-00-38d; lot# 37761901, 22.2 mm std lfit v40 head; cat# 6260-9-122; lot# 37430203, rejuvenate strght prfit tmzf 132 mono stem size 6; cat# spt-063400s; lot# mhp71m, 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 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.
Event or Problem Description
Patient is part of the tritanium primary acetabular shell study and reported pain in the study hip during the 6 and 7-year visits, respectively.Patient reported right hip pain at night during the 6-year visit ((b)(6) 2017) and continued right-hip pain during the 7-year visit ((b)(6) 2018).Patient has not been revised as of the event date.

• 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: 9087584
• Report Number: 0002249697-2019-03275
• Device Sequence Number: 2537722
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 08/31/2016
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 37727301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: Other
• Patient Age: 81 YR
• Patient Weight: 74