MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; IMPLANT

Catalog Number 1236-2-848

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported that patient underwent multiple revisions for infection following primary tha at an outside institute.Two revisions reported separately.

Manufacturer Narrative

Additional devices listed in this report: cat 626-00-42e mdm liner cementless lot code 46192603, cat 18-28-3 biolox delta ceramic c taper femoral head lot code 32761101.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Manufacturer Narrative

Additional devices listed in this report: cat 626-00-42e mdm, liner cementless, 42mm lot code 46192603, cat 18-28-3 biolox delta ceramic c-taper femoral head, 28mm lot code 32761101, cat 6051-0730s secur-fit max, 132 neck angle hip stem lot code mjtkew, cat 2080-0040 restoration gap plate screw, 6.5mm lot code mna848.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that patient underwent multiple revisions for infection following primary tha at an outside institute.2 revisions reported separately.Update, doa (b)(6) 2014: it was reported that the patient had a revision due to prosthetic joint infection.I&d took place with poly exchange and mdm products removed on (b)(6) 2014.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: IMPLANT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4353224
• MDR Text Key: 5145663
• Report Number: 0002249697-2014-04831
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 47662701
• Other Device ID Number: STERILE LOT 1404N261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2014
• 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
• Patient Age: 59 YR
• Patient Weight: 88