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

Model Number 6570-0-536

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported that the patient's left hip was revised.An office note cites the following: left hip discomfort, numbness, limb length discrepancy, subluxation/ dislocation, stem subsidence.Surgeon reported that the shell was retroverted and vertical.All components were revised.Rep provided an office note and the primary operative report and confirmed that no further information will be released by the hospital or surgeon.

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.

Manufacturer Narrative

Reported event an event regarding limb length discrepancy and instability 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 was not returned -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event cannot be confirmed without additional medical records.A revision surgery was proposed but not confirmed.Root cause: the root cause for the proposed revision would be as stated in the note: leg length discrepancy and hip instability.These cannot be confirmed without operative notes and addition medical records.-product history review: all 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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device are needed to complete the investigation for determining root cause.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

It was reported that the patient's left hip was revised.An office note cites the following: left hip discomfort, numbness, limb length discrepancy, subluxation/ dislocation, stem subsidence.Surgeon reported that the shell was retroverted and vertical.All components were revised.Rep provided an office note and the primary operative report and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+2,5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12775537
• MDR Text Key: 282770781
• Report Number: 0002249697-2021-01858
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540608574
• UDI-Public: 04546540608574
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2022

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: 6570-0-536
• Device Catalogue Number: 6570-0-536
• Device Lot Number: 81036803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG