MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6570-0-132
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted ceramic head with black smears on one side as evidence for past dislocations through contact with the shell rim metal.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: conclusion of assessment: a marginally stable hip arthroplasty was present in 2014 with cup malposition in low inclination, mainly due to inappropriate use of a10° offset liner in combination with a slightly short leg in the hip joint due to inadequate reconstruction of femoral head neck length.The marginal stability of the arthroplasty was further compromised after the first hip dislocation associated with a fall of the patient in 2018.This caused rupture of the hip capsule with loss of soft tissue stability in the joint and no prospect of adequate capsular healing due to further recurrent dislocation in short intervals.Recurrent dislocation required revision surgery with exchange of the bearing for an mdm construct with longer femoral head in (b)(6) 2019.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 05 other similar events for the reported lot.(b)(4) relates to crack/fracture, (b)(4) relates to dislocation, incorrect selection and limb length discrepancy for the same device and patient, therefore no further trending is required for this commonality.Conclusion: the investigation concluded that limb length discrepancy was caused by incorrect selection of a 32-mm/+0 femoral head resulting in a slightly short left leg which contributed to the recurrent dislocations which led to this revision surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
Booked revision case due to dislocation post previous fracture.Head and liner revised from +0 head to +8 head and mdm.Mdm trialed on table and case completed.This pi is for the dislocation.Update: 02 april 2019: this patient has had multiple closed reductions for dislocation.These dislocations are covered under (b)(4).This revision was due to the recurrent dislocations however the patients hip was not dislocated at the time of revision surgery.Medical review has identified incorrect use of 10degree liner and ceramic head (32/0) leading to limb length discrepancy and recurrent dislocation.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8568771
• Report Number: 0002249697-2019-01799
• Device Sequence Number: 19229300
• Product Code: JDI
• UDI-Device Identifier: 04546540608505
• UDI-Public: 04546540608505
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 6570-0-132
• Device Lot Number: 43466701 43466702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 85