MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-021; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-021
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: mod con dist stem 17 x 155 mm; cat# 6276-7-017; lot# caxjc13f; v40 cocr lfit head 36mm/+5; cat#6260-9-236; lot# mle96d; trident x3 eccentric 10° 36mm id; cat# 663-10-36e; lot# mljad5; trident hemispherical multi; cat# 508-11-52e; lot# 30945401; 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# mll7n8; 6.5 cancellous bone screw 35mm; cat# 2030-6535-1; lot# mlkx6j; 6.5 cancellous bone screw 16mm; cat# 2030-6516-1; lot# mkev3p; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the reported device is not available for evaluation.A 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
It was reported that the patient's left hip was revised due to infection and elevated ion levels as well as suspected trunnionosis.A 36 +5 metal head and restoration modular stem construct were revised.Rep provided an x-ray, primary operative report, primary implant sheet, and explant picture, and reported that no further information is available.

• Brand Name: 21MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-021
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8420901
• Report Number: 0002249697-2019-01325
• Device Sequence Number: 1795513
• Product Code: LPH
• UDI-Device Identifier: 04546540641076
• UDI-Public: 04546540641076
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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: 01/31/2016
• Device Catalogue Number: 6276-1-021
• Device Lot Number: 35166602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: 70 YR