MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	UNKNOWN
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: device name#: delta v-40 ceramic head 36/+2,5 ; cat#: 6570-0-536 ; lot#: 1219102s.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
Event or Problem Description
Patient admitted for revision surgery, indicated due to periprosthetic infection.Stryker device explanted, and competitor items implanted.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving an exeter stem was reported.The event was not confirmed.Method & results: -product evaluation and results: visual analysis of the explanted stem had nothing of relevance to note.The image shows the device with the ceramic head still attached.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: 'this inquiry concerns a patient who underwent a stryker total hip arthroplasty at some point in the past.He then developed a periprosthetic infection which required removal of the implant and revision surgery with a competitor product.Conclusion of assessment: this case involves a patient who developed a periprosthetic infection following primary total hip arthroplasty.Very little specific information was given.I can confirm that the patient had a stryker total hip arthroplasty since i was able to see an x-ray of the device.I can also confirm that the patient underwent explantation of the stryker implant because i was able to see a photograph of the explanted device.I cannot confirm the revision surgery since i have no operation report, office notes or post revision x-ray.I have no information about how long after the index surgery the infection developed.The root cause of periprosthetic infection is multifactorial.It includes surgical technique factors such as contamination at surgery, or contamination due to a draining wound, patient factors including postoperative instruction compliance with possible contamination of the wound.Infection can also occur from a remote source with seeding of the implant.I would not assign any causality to the implant itself.' -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: clinician review of the medical records did not confirm this event.The exact cause of the event could not be determined because insufficient information was provided.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.Additional information including pathology reports, operation report, office notes, post revision x-ray and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient admitted for revision surgery, indicated due to periprosthetic infection.Stryker device explanted, and competitor items implanted.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15593205
• Report Number: 0002249697-2022-01482
• Device Sequence Number: 2136655
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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 Model Number: UNKNOWN
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G8354308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 108 KG