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

Model Number	6570-0-736
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty (b)(6) 2019.Patient underwent revision left total hip arthroplasty on the left side, both components changed for closure of dehisced left hip surgical wound on (b)(6) 2020.The patient was having instability so underwent a second revision on (b)(6) 2020.Only the liner and the head were exchanged.
Event or Problem Description
Procedure: the patient underwent left total hip arthroplasty (b)(6) 2019.Patient underwent revision left total hip arthroplasty on the left side, both components changed for closure of dehisced left hip surgical wound on (b)(6) 2020.The patient was having instability so underwent a second revision on (b)(6) 2020.Only the liner and the head were exchanged.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to instability involving a ceramic head was reported.The event was confirmed by medical review.Method & results: not performed as product was not returned.Clinical review: clinical review: a review of the provided medical records by a clinical consultant stated the following comment: power point slides: slide 1: dos (b)(6) 2019, rev 1 (b)(6) 2020 (7 days) wound dehiscence poly and head exchange, rev 2 (b)(6) 2020 (178 days) instability- head and poly exchange.Slide 2: ¿preop x-ray¿ ap pelvis lat left hip, note spine fusion.Slide 3: (b)(6) 2019: op note, primary tha avn and head fx, uncomplicated tha (50 mm trident multihole, accolade 2 1270 size 3, x3 x 36mm liner, delta 36 +7.5mm head, screws not noted).Slide 4: undated ap pelvis x-ray implants appear as above.Slide 5: no image ¿pre-revision.¿ slide 6: (b)(6) 2020: op note, wound dehiscence following tha, 5cm at proximal incision, to or for i and d, head and liner exchanged, no obvious infection.Slide 7: undated left ap hip x-ray ¿post-revision¿ with apparent components as above.Slide 8: (b)(6) 2020: op note, revision tha for instability, placed constrained liner and 22mm +8mm head cocr, descried as posterior.Slide 9: ¿post revision¿ x-ray eft hip ap and lateral, same stem and shell with constrained liner, there is questionable seating of the liner event confirmation: the event was confirmed: revision for ¿dehiscence¿, second revision for instability.Root cause: the root cause of the revision was the wound dehiscence.The cause of the dehiscence was less clear, it could be technical, due to lupus/steroids, or infection (none noted).The cause of the instability was likely poor tissue in the face of a spine fusion.Assessing implant position would require ct or other modality.Reviewing additional medical records could add to the analysis.Note there is a question of malposition of the new constrained liner.The event was unrelated to the implants.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 reported lot.  conclusions: an event regarding revision due to instability involving a ceramic head was reported.The event was confirmed based on medical review.The exact cause of the event could not be determined because insufficient information was provided.However, as per medical review the cause of the instability was likely poor tissue in the face of a spine fusion.Assessing implant position would require ct or other modality.Reviewing additional medical records could add to the analysis.Further information is needed to complete the investigation for determining its root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11107244
• Report Number: 0002249697-2021-00002
• Device Sequence Number: 4042243
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 11/30/2024
• Device Model Number: 6570-0-736
• Device Catalogue Number: 6570-0-736
• Device Lot Number: 75878101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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: 59 YR
• Patient Weight: 78