MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 27MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-227; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-227
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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: delta v-40 ceramic head 32/-4; cat#6570-0-032; lot#61256902 bowed conical stem 19 x 195mm restoration modular hip system; cat#6276-7-219; lot#caxt90wa.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#66826307.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#66826307.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#61682902.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#63677510.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#66505402.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#64867403.Md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#63014803.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to infection.A 27 +20 restoration modular proximal body and 32 -4 biolox head were revised to 25 +20 v40 restoration modular proximal body and 32 +4 lfit v40 head.

• Brand Name: 27MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-227
• 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: 8440952
• Report Number: 0002249697-2019-01404
• Device Sequence Number: 344883
• Product Code: LPH
• UDI-Device Identifier: 04546540641243
• UDI-Public: 04546540641243
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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: 01/31/2020
• Device Catalogue Number: 6276-1-227
• Device Lot Number: 50071301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/21/2019
• 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: 52 YR