MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-126

Device Problems Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091); Injury (2348)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cat #6721-0330, lot #51339307, description: size 3 accolade ii 127 deg; cat #uh1-45-26, lot #hv4e0k, description: uhr bipolar 26x45mm.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The patient experienced redness, swelling, and infection after the primary surgery.The patient had an infection so an i&d was performed along with a head replacement.

Manufacturer Narrative

An event regarding infection involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: no information was received for review with the clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar relevant events for the reported lot or sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pathology reports, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

Event Description

The patient experienced redness, swelling, and infection after the primary surgery.The patient had an infection so an i(b)(4) was performed along with a head replacement.

• Brand Name: 26MM STD LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5638156
• MDR Text Key: 44662714
• Report Number: 0002249697-2016-01545
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 6260-9-126
• Device Lot Number: 52889203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 95 YR
• Patient Weight: 47