MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32X52-55MM 10 DEG INS DURAT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6299-7-525
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: 25mm mod rev hip body/bolt stdcomponent level 9006-1-025; cat# 6276-1-025; lot# 44696902; delta v-40 ceramic head 32/0; cat# 6570-0-132; lot# 60098701; 17mm x 217mm bowed plasma stemrestoration modular hip system; cat# 6276-5-417; lot# 44225201; md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 62586320; md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 63041205; md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 63014803; md vit slv and 2.0mm homog cbl; cat# 6704-0-510; lot# 63014803; 17mm x 267mm bowed plasma stemrestoration modular hip system; cat# 6276-5-517; lot# 51757401.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 reported discrepancies.There have been no other events for the lot referenced.There have been no other events for the sterile 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
It was reported that patient's right hip was revised.As reported by rep: "patient had an infection and had some components exchanged during the i and d".

• Brand Name: 32X52-55MM 10 DEG INS DURAT
• 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: 7637843
• Report Number: 0002249697-2018-01964
• Device Sequence Number: 1432996
• Product Code: LPH
• UDI-Device Identifier: 04546540268303
• UDI-Public: 04546540268303
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 01/31/2021
• Device Catalogue Number: 6299-7-525
• Device Lot Number: 54367301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/26/2018
• 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: 76 YR