MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-12-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Anxiety (2328); Distress (2329); Deformity/ Disfigurement (2360); Fibrosis (3167); Limb Fracture (4518); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Litigation complaint received ad 7 jul 2022.Claim letter alleges breathing difficulties, very high levels of metal toxicity.Patient was revised was due to metallosis, a tumor, cysts and necrotizing tissue.Doi: 18 years ago.Dor: (b)(6) 2022.Unk hip.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Affected side is right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update (b)(6) 2022: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

The patient was alleged to experience pain, increased metal levels in blood including cobalt and chromium, injuries, emotional distress, and disfigurement.Doi: (b)(6) 2007.Dor: (b)(6) 2022.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: e1 (law firm), e3 (initial reporter occupation: (b)(6)), d6a, h6 ((health effect-clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received and stated the following: pfs alleges injuries on tendons, ligaments, tissues, bones within right hip.Plaintiff suffered extreme pain, trochanteric fractured, elevated metal ions, pseudotumor, metallosis and anxiety.After review of the medical records the patient was revised to address hip pain, elevated metal ions, fractured greater trochanter, pseudotumor, metallosis, trunnionosis and vertical cup.Operative note reported metallosis in the posterior capsule.There was fluid in the hip, trunnionosis in the femoral head.Pseudotumor appear to track up the iliopsoas.There was leg length discrepancy.Doi: (b)(6) 2007;dor: (b)(6) 2022; right hip.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: a2 (age, dob), a4, b5, b6, b7, d1, d2a, d2b, d4 (lot, udi), d10, g4 (pma), h4, h6 corrected: b3, d4 (catalog).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (clinical codes) h6 clinical code: swelling/ edema (e2338) is used to capture swelling and edema.Unspecified tissue injury (e2015) is used to capture soft tissue injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT DUOFIX TAP SZ5 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15085480
• MDR Text Key: 296400545
• Report Number: 1818910-2022-13719
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060161
• UDI-Public: 10603295060161
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/22/2022

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: 1570-12-110
• Device Catalogue Number: 157012110
• Device Lot Number: BS5DYA000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 07/29/2022; 01/03/2023; 03/08/2023; 07/06/2023
• Supplement Dates FDA Received: 07/26/2022; 08/01/2022; 01/05/2023; 03/08/2023; 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2007
• 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
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; ASR UNI FEMORAL IMPL SIZE 49; SUMMIT DUOFIX TAP SZ5 HI OFF; UNK HIP ACETABULAR CUP ASR; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 107 KG