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

Model Number 623-00-36F

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Depression (2361); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: tridentii tritanium cluster56f; cat# 702-04-56f ; lot# 74860701a.6.5mm low profile hex screw 30mm; cat# 7030-6530 ; lot# 4akh.6.5mm low profile hex screw 25mm; cat# 7030-6525 ; lot# 4tud.Size 5 accolade ii 127 deg; cat# 6721-0535 ; lot# 76417002.Delta v-40 ceramic head 36/-5; cat# 6570-0-036 ; lot# 78109702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient reported he had a left tha done on (b)(6) 2020.Patient stated that right after surgery he told the surgeon that his leg was longer.Patient started to experience pain right after surgery and the pain hasn't stopped.Patient had 6-8 sessions of physical therapy.Patient stated that during one of his office visits the surgeon told him he had a leg discrepancy of an inch longer.Patient sought a second opinion and had an mri and was given cortisone for the pain.Patient is limping, he¿s unable to bend and has back issues.Patient would like to confirm if his implants are part of recall.Patient has been experienced depression as he is now unable to work and the issues he has been experiencing.Patient would like assistance with his hip revision.

Manufacturer Narrative

Corrected data - d1, d4.Reported event: an event regarding limb length discrepancy involving a ceramic head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient is experiencing a leg discrepancy of an inch longer.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It is noted that the patient is inquiring if the implants are part of a recall.Based on the catalog numbers provided no product reported in this record is subject to a product recall.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported he had a left tha done on (b)(6) 2020.Patient stated that right after surgery he told the surgeon that his leg was longer.Patient started to experience pain right after surgery and the pain hasn't stopped.Patient had 6-8 sessions of physical therapy.Patient stated that during one of his office visits the surgeon told him he had a leg discrepancy of an inch longer.Patient sought a second opinion and had an mri and was given cortisone for the pain.Patient is limping, he¿s unable to bend and has back issues.Patient would like to confirm if his implants are part of recall.Patient has been experienced depression as he is now unable to work and the issues he has been experiencing.Patient would like assistance with his hip revision.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/-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 NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13855858
• MDR Text Key: 288119450
• Report Number: 0002249697-2022-00423
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 623-00-36F
• Device Catalogue Number: 6570-0-036
• Device Lot Number: 78109702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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
• Patient Age: 46 YR
• Patient Sex: Male