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

Model Number	6260-9-028
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	01/14/2020
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.Not returned.
Event or Problem Description
As reported: "femoral head swap.".
Event or Problem Description
As reported: "femoral head swap." update: medical records indicate the reason for revision is acetabulum component loosening.It is unknown if the acetabulum component is stryker product.
Additional Manufacturer Narrative
An event regarding acetabular cup loosening involving a femoral head was reported.Conclusion: revision surgery took place due to acetabulum component loosening.Loosening refers to loss of fixation between bone and implant/bone cement or failure to fixate.The femoral head has no direct contact with the patients bone.The hip liner including femoral head "block" access to the joint space and therefore with almost any revision surgery for whatever reason, these components are removed, more so because they are usually modular and removal is easy and straightforward.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.A full investigation cannot be completed at this time as it is unknown if the acetabulum component is stryker product.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 28MM -4 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9693262
• Report Number: 0002249697-2020-00257
• Device Sequence Number: 1691059
• Product Code: JDI
• UDI-Device Identifier: 07613327012996
• UDI-Public: 07613327012996
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 12/31/2008
• Device Model Number: 6260-9-028
• Device Catalogue Number: 6260-9-028
• Device Lot Number: 7436201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/09/2020
• 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
• Patient Age: 77 YR
• Patient Weight: 47