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

Model Number 1570-11-110

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

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 07/10/2020

Event Type  Injury  

Event Description

Asr litigation complaint received ad 27 jun 2022.Litigation records alleges pain, discomfort, increased metal level in blood including cobalt and chromium, injury, emotional distress, disability, disfigurement and economic changes.Doi: (b)(6) 2007, dor: (b)(6) 2020, left hip.

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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: a4, b5, b7, d4 (lot, udi), g4, h4 and h6 (clinical code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, d1, d2, d4 (catalog), d6a and d10.

Event Description

Pfs alleges pseudotumors and metallosis.

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 a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: removed: h7 and h9 since the device involved is not an asr product.

Event Description

After review of medical records patient was revised due to wear of articular bearing surface of internal prosthetic left hip joint.Operative notes indicated soft tissue mass approximately 12cm diameter beginning at the distal aspect prior to incision extending distally.The mass was incised gently and there was egress of copious amounts of cloudy milky fluid which was suctioned.Mri showed cystic soft tissue mass extending through the fascia to the hip.There was mild to moderate dark staining of the synovial tissue and minimal trunnionosis.

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.

• Brand Name: SUMMIT POR TAPER 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 drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15005711
• MDR Text Key: 295856118
• Report Number: 1818910-2022-12976
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2022

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: 1570-11-110
• Device Catalogue Number: 157011110
• Device Lot Number: CB6DG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/19/2022; 08/01/2022; 09/19/2022; 10/06/2022
• Supplement Dates FDA Received: 07/19/2022; 08/02/2022; 09/30/2022; 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2.; ASR ACETABULAR CUPS 56.; ASR UNI FEMORAL IMPL SIZE 49.; 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: 57 YR
• Patient Sex: Male
• Patient Weight: 73 KG