MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PRO ACETABULAR PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abscess (1690)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf report from (b)(6) medical center.The title of this report is ¿a retrospective data collection of the treatment of pelvis and acetabulum fractures with the pro system.¿ which is associated with the ¿pro pelvis and acetabulum system'.Within that report, post-operative complications/ adverse events were reported which occurred between 2011 - april 2019.It was not possible to ascertain specific device catalog or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 4 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses osteomyelitis of the hip requiring eventual conversion to total hip arthroplasty.4 out of 4 cases.The pmcf report states, ¿the patient developed a deep wound abscess at 2 weeks postoperatively.The patient required multiple debridements.The fracture was consolidated by 6 months, but the wound abscess had not resolved at that time.The patient went on to develop chronic osteomyelitis of the hip, requiring eventual conversion to total hip arthroplasty.

• Brand Name: UNKNOWN PRO ACETABULAR PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9079547
• MDR Text Key: 163206002
• Report Number: 0008031020-2019-01282
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention