MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+7,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-736
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Injury (2348)
Date of Event	01/03/2020
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.Device not returned.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty (b)(6) 2019.Patient underwent revision left total hip arthroplasty on the left side, both components changed for closure of dehisced left hip surgical wound (b)(6) 2020.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty (b)(6) 2019.Patient underwent revision left total hip arthroplasty on the left side, both components changed for closure of dehisced left hip surgical wound (b)(6) 2020.
Additional Manufacturer Narrative
Corrected: expiration date.Reported event: an event regarding patient factors involving a ceramic head was reported.The event was confirmed through clinician review of the the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: hazard: none clearly related to implant.Conclusion of assessment: immunosuppressed patient did return to or for an i and d.Head and liner exchange were performed.The event was unrelated to implants.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the patient was revised due to patient factors ( closure of wound dehisced).A review of the medical records indicated immunosuppressed patient did return to or for an i and d.Head and liner exchange were performed.The event was unrelated to implants.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• 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: 10458028
• Report Number: 0002249697-2020-01739
• Device Sequence Number: 16859401
• Product Code: JDI
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 04/30/2023
• Device Model Number: 6570-0-736
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 64763401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: 59 YR
• Patient Weight: 79