MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-232
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Suspected infection.Pain.Osteolysis in the proximal part of the femur and a tumor-like substance can be confirmed on ct.Wear of head and tmzf cannot be denied.Revision will be done on june 9.
Event or Problem Description
Suspected infection.Pain.Osteolysis in the proximal part of the femur and a tumor-like substance can be confirmed on ct.Wear of head and tmzf cannot be denied.Revision will be done on june 9.
Additional Manufacturer Narrative
An event regarding infection, wear and osteolysis involving a ceramic head was reported.The event was not confirmed.Method & results -product evaluation and results:visual inspection: visual inspection of the returned device indicates damage on the surface of the ceramic head can be observed.Ma - not performed because the device was returned damaged.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: not performed because the device was returned damaged.-clinician review:a review of the provided medical records by a clinical consultant stated the following comment: x-rays: (b)(6) 2015 ap and lat.Left hip: uncemented tha, reduced, nominal, skin staples in situ.(b)(6) 2020 ap and lat.Left hip no migration of components, no pathology, mild stress shielding proximal femur.(b)(6) ap and lat.Left hip no migration of components, increased radiolucencies noted around junction of mid and distal 1/3 of stem on ap view.No clinical or pmh, no patient demographics, no lab.Studies, no operative reports, no confirmation that revision surgery was performed or findings during such surgery.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.-device 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 or sterile lot.Conclusion:  all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.  additional information including pathology reports, operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• 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: 12104247
• Report Number: 0002249697-2021-01120
• Device Sequence Number: 17193351
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 02/29/2020
• Device Model Number: 6570-0-232
• Device Catalogue Number: 6570-0-232
• Device Lot Number: 50868702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: 78 YR