MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CORK_PRODUCT; IMPLANT

Catalog Number UNK_SHC

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Date 04/06/2015

Event Type  Injury  

Event Description

The representative reported on behalf of the surgeon who had undertaken a secondary revision of a hip, that there had been a 'reaction' between the cabling system, grip plate and the restoration modular cone body.The representative reported that the surgeon did not give a specific event description although a possible fracture or a general demise in the hip were discussed.The surgeon did not indicate that this reported event in relation to the dall miles was the primary reason for the revision.Updated information indicates that the patient had her original revision done in (b)(6) 2011 at the princess royal hospital haywards heath.It came up for revision in (b)(6) 2015 due to pain and suspected loosening.The customer reported that original x-rays confirmed there was no metal on metal interaction between the restoration implants and dall-miles implants.X-rays pre op from (b)(6) 2015 showed bone loss and potential metal on metal interaction.The customer reported that upon revising the hip in (b)(6) 2015, substantial amounts of black tissue were removed and the surgeon suspected some form of metallosis.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown dall miles grip plate.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

• Brand Name: UNKNOWN_CORK_PRODUCT
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4791623
• MDR Text Key: 15566563
• Report Number: 0002249697-2015-01636
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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): Hospitalization; Required Intervention