MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SUMMIT POR TAPER SZ1 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-070
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/17/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #; (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation alleges the patient suffers from large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update ad 17 jun 2021.(b)(4) has been re-opened under (b)(4) due to receipt of pcf and medical records.After review of medical records it was reported that the patient complained of pain, fatigue, diff walking, crouching and sleeping with increase cobalt and chromium levels.The patient was then revised for possible tissue reaction left tha, metal on metal.Operative notes reported that patient has bilateral hip implants.Left side been slightly painful.On note there did not appear to be any adverse wear on the inside aspect of the acetabular shell nor over the trunnion or inside the femoral head.No labs provided for the alleged elevated metal ions.Pathology reported of trunnion left hip for metal debris.Acellular fibrinous material with small number of microscopic particles compatible with metallic debris.The specimen consist of several fragments of pink-purple irregular shape, evaluate for alval.X-rays reported of trochanteric bursitis.Mri reported of pseudotumor, lysis, effusion and erosion.Doi: (b)(6) 2011.Dor: (b)(6) 2013.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ1 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• MDR Report Key: 12092684
• Report Number: 1818910-2021-13933
• Device Sequence Number: 4898247
• Product Code: KWA
• UDI-Device Identifier: 10603295060024
• UDI-Public: 10603295060024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2014

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 1570-11-070
• Device Catalogue Number: 157011070
• Device Lot Number: E5VCE1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/11/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINN 100 W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT POR TAPER SZ1 HI OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINN 100 W/GRIPTION 50MM; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT POR TAPER SZ1 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR