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 Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Anxiety (2328); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 12/03/2021

Event Type  Injury  

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

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from the toxic heavy metals resulting to muscle, tissue and bone injury, metallosis, metal wear, scar tissue formation, pain and limited adl.Also suffered emotional trauma and distress.Doi: (b)(6) 2010; dor: (b)(6) 2021; 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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: h6 clinical codes: metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture soft tissue injury and bone injury.

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

After review, patient was revised due to metallosis with synovitis.Evidence of corrosion at trunnion of stem and at liner cup interface.Posterior soft tissue sleeve and abductors intact.Large osteolytic defect in right femur greater trochanter.Components well fixed and in acceptable position.Osteolysis around superior rim of acetabular component.However, there was no gross evidence of infection.There was gross evidence of trunnionosis with black grey corrosion products evident.The acetabular liner was removed revealing corrosion behind the 40 mm cobalt chrome liner.Doi: (b)(6) 2010, dor: (b)(6) 2021, affected side: 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays evidence were reviewed, and nothing indicative of a device nonconformance was observed, therefore the reported allegation was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays evidence were reviewed, and nothing indicative of a device nonconformance was observed, therefore the reported allegation was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

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.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 received.In addition to what was previously reported in the medical records the patient was revised to address depression, walking difficulty and metallosis.Clinical visit reported persistent focus of ossification of the right greater trochanter.Surgical pathology reported tissue reaction to particulate implant material and in the soft tissue metallic particulate debris and corrosion products.Although there is abundant corrosion product and metallic pigment with synovial tissue, there is not a significant alval indicative of an immunogenic reaction.Femoral head shows circular abrasive wear.Microscopic description demonstrate interface synovial like tissue showing dense and diffuse sub synovial fibrosis and are foci of reactive appearing synovial hyperplasia.Mri hips shows pseudotumor, elevated metal ions, lateral pain and bursitis.

Event Description

The patient was revised to address osteolysis, stiffness, limited mobility, adl, and anxiety.Head and liner were exchanged and femoral bone allographs were performed.The operative note reported metallosis with synovitis.There was evidence of corrosion at the trunnion stem and liner cup interface.Large osteolytic defect in the right femur greater trochanter.Osteolysis around the acetabular component.There was evidence of trunnionosis with black grey corrosion in the head.Scar tissues were excised.Clinical visit reported mild tenderness over the greater trochanter, and mild nonspecific synovial expansion more evident on the right side.There are hypointense foci likely related to metal debris and osteolysis in the proximal femur, metallosis, adverse local tissue reaction, and elevated metal ions.However, the lab result is below 7 ppb.

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: a2 (age), a4, a5, a6, b5, b6, g4, h4 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D1, d2, d4, d6b (removed the date of explant) and d10.

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.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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14874975
• MDR Text Key: 295050114
• Report Number: 1818910-2022-12076
• 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: 06/30/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2019
• Device Model Number: 1570-12-110
• Device Catalogue Number: 157012110
• Device Lot Number: D77LN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/04/2022; 03/13/2023; 03/28/2023; 04/18/2023; 05/22/2023; 06/12/2023; 08/17/2023; 10/13/2023
• Supplement Dates FDA Received: 07/06/2022; 03/14/2023; 04/06/2023; 04/18/2023; 06/06/2023; 06/12/2023; 08/25/2023; 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2009
• 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: APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 40 +8.5; PINNACLE 100 HA ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White