MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-12-120

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

Patient Problems Emotional Changes (1831); Erythema (1840); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The surgeon states patient has an asr and is having increased pain, elevated metal ions, significant osteolysis, and no instability.The surgeon revised to pinnacle cup, poly liner, and a ceramic head.To answer the question below, no instruments were broken in case, therefore no instruments were removed from the patient." doi: (b)(6) 2006, dor: (b)(6) 2021, affected side: 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.

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.

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.E3 initial reporter occupation: lawyer.H6 (health effect - clinical code): metal related pathology (e1618) is being utilized to capture blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Update ad 18 jul 2022 additional information received from aei note (b)(4).Litigation records received.In addition to what was previously alleged, records alleges discomfort, emotional distress, disability and disfigurement.

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.Update 20-july-2022 received did not have any additional details to be added in investigation.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

On july 14, 2021, patient had revision and operative reported trunnion addressed, that a little corrosion left.

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: 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.-------------------------------------------------------- update: (b)(6) 2022.Update received on (b)(6) 2022, did not have any additional details to be added in investigation.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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H6: (clinical codes) corrected.

Event Description

Patient had metal staining throughout the tissues.And some small pseudotumor formation in the posterior and inferior capsular areas, that was carefully debrided.Patient alleges stiffness, soreness in right hip, anxiety, fear, and metallosis.

• Brand Name: SUMMIT DUOFIX TAP SZ6 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12278533
• MDR Text Key: 265136508
• Report Number: 1818910-2021-17076
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-12-120
• Device Catalogue Number: 157012120
• Device Lot Number: A4VEA1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/03/2021; 08/10/2021; 07/18/2022; 07/20/2022; 08/02/2022; 08/23/2022; 09/28/2022
• Supplement Dates FDA Received: 08/06/2021; 08/12/2021; 07/19/2022; 07/21/2022; 08/15/2022; 08/24/2022; 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2006
• 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 +2; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; SUMMIT DUOFIX TAP SZ6 HI OFF; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 86 KG