MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/-2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 6570-0-436

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

The 36mm -2.5 biolox ceramic head v40 taper didn't successfully sit onto accolade ii v40 trunnion.Surgeon unsure if soft tissue impingement caused the head to not sit properly, however decided to open and use a different femoral head.Hospital staff discarded of implant per hospital protocol.

Manufacturer Narrative

An event regarding a size/fit issue involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as device was not returned.Medical records received and evaluation: a medical review was not performed because no information was provided.Device history review: a review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: a review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product return is needed to complete the investigation for determining a root cause.

Event Description

36mm -2.5 biolox ceramic head v40 taper didn't successfully sit onto accolade ii v40 trunnion.Surgeon unsure if soft tissue impingement caused the head to not sit properly, however decided to open and use a different femoral head.Hospital staff discarded of implant per hospital protocol.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/-2,5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6597507
• MDR Text Key: 76381715
• Report Number: 0002249697-2017-01712
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540608567
• UDI-Public: (01)04546540608567(11)170215(17)220215(10)58773201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 6570-0-436
• Device Catalogue Number: 6570-0-436
• Device Lot Number: 58773201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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): Other