MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM -4 V40 TAPER VIT HEAD; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS

Model Number	6260-5-028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The doctor revised the patient's total hip prosthesis due to the breakage of the exeter nail implanted in the patient.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture of the exeter stem involving metal head was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.The device was returned assembled to the mated exeter stem.Nothing remarkable was observed on the device.During revision surgery, it is considered good surgical practice to always replace bearing components such femoral head with new devices, also because service life damage or wear is not always readily visible and these components are usually modular and removal is easy and straightforward.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The doctor revised the patient's total hip prosthesis due to the breakage of the exeter nail implanted in the patient.

• Brand Name: 28MM -4 V40 TAPER VIT HEAD
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10559259
• Report Number: 0002249697-2020-01948
• Device Sequence Number: 14147934
• Product Code: JDI
• UDI-Device Identifier: 07613327012835
• UDI-Public: 07613327012835
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 06/30/2018
• Device Model Number: 6260-5-028
• Device Catalogue Number: 6260-5-028
• Device Lot Number: 44032102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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