MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	1236-2-858
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: delta v-40 ceramic head 28/+4; cat# 6570-0-228 ; lot# 66768702.Mod con dist stem 14 x 155 mm; cat# 6276-7-014; lot# caxx900a.21mm mod rev hip body/bolt std component level 9006-1-021; cat# 6276-1-021; lot# 71134801 modular dual mobility insert; cat# 626-00-52h; lot# 69528702.Trident ii tritanium multi 64h; cat# 709-04-64h; lot# 72256201a.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 5m4.6.5mm low profile hex screw 15mm; cat# 7030-6515; lot# 5x4.6.5mm low profile hex screw 15mm; cat# 7030-6515; lot# 6vw.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 6cye.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# 4tua.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported "surgeon did a head exchange due to possible infection.X-ray, original [usage] sheet, revision.[usage] sheet all attached.No other information available per hospital policy." the femoral head and adm/ mdm insert were revised.

• Brand Name: RESTORATION ADM X3 INS 28/58
• 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
• MDR Report Key: 9484893
• Report Number: 0002249697-2019-04041
• Device Sequence Number: 366119
• Product Code: MEH
• UDI-Device Identifier: 04546540639028
• UDI-Public: 04546540639028
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 12/31/2019
• Device Catalogue Number: 1236-2-858
• Device Lot Number: 50338301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/17/2019
• 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: 69 YR