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

Catalog Number 6570-0-736

Device Problems Out-Of-Box Failure (2311); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

During a primary hip surgery, right after opening the implant and right before implanting, the doctor noticed a small scratch on the surface of the biolox ceramic head.A new head was opened and implanted.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding the appearance of a ceramic head was reported.The event was confirmed based on the scratching identified.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Images of the device are included in the mar."visual appearances indicated that these markings were likely from contact with a metallic object.Figure 3 shows the mark on the articulating surface of the head.Figure 4 shows similar markings inside the female taper where the hip stem trunnion seats.These markings are consistent with inserting the hip stem trunnion into the head with the typical twisting motion used to remove the head from the trunnion." the mar concluded: "the markings on the ceramic head occurred from contact with a ti-based metal.The likely source would be during surgery.No material or manufacturing defects were observed on the surfaces examined" medical records received and evaluation: not performed, no patient information was provided and no adverse consequences to the patient were reported.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a material analysis was performed and concluded that "no material or manufacturing defects were observed on the surfaces examined".The origin of the markings on the ceramic head likely resulted during surgery.A review of this issue was also performed by the operations support team.No evidence was found to suggest the issue arose during the processing and packaging of the device.No further investigation is required at this time.If further relevant information becomes available, this investigation will be re-opened.

Event Description

During a primary hip surgery, right after opening the implant and right before implanting, the doctor noticed a small scratch on the surface of the biolox ceramic head.A new head was opened and implanted.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4869617
• MDR Text Key: 6260445
• Report Number: 0002249697-2015-02087
• Device Sequence Number: 1
• Product Code: LZO
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 51232703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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