MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 523418

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.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.(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

Pinnacle claim letter received.Letter alleges pain, discomfort, difficulty walking, elevated cobalt 13.6ug/l and chromium 41.3 ug/l level, pseudotumor and metallosis.Doi: (b)(6) 2008 dor: (b)(6) 2020 left hip.

Event Description

After review of medical records in addition to what previously alleged, patient was revised to addressed instability.

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 and date of birth), a3, a4, b5, b6, b7, d4 (lot #, udi and expiration date), e1, 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), d10 and g1.

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.H6 clinical code: unspecified tissue injury (e2015) captures 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.

Event Description

In addition to what was previously alleged, litigation records alleges tissue and bone destruction, metal wear, emotional trauma and distress.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update (b)(6) 2022: the investigation was re-opened upon receipt of additional information.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.Device history lot: a manufacturing record evaluation was performed for the finished device product code 523418, lot#2581052, and no non-conformances / manufacturing irregularities were identified.

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 complaint was not returned.X-ray evidence provided was reviewed and found no implant issue.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 record evaluation was performed for the finished device product code 523418, lot#2581052, and no non-conformances / manufacturing irregularities were identified.

Event Description

Additional information was received and stated that the clinical visit reported elevated metal ions, leukocytosis with a white count of 126000, ct scan reported numerous bilateral cervical lymph nodes and sclerotic changes in the right femoral head suggestive of osteonecrosis, non hodgkin's lymphoma disorder and chronic lymphocityc leukemia.Doi: (b)(6) 2008; dor: (b)(6) 2020; left hip.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11614678
• MDR Text Key: 243798943
• Report Number: 1818910-2021-07000
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2013
• Device Catalogue Number: 523418
• Device Lot Number: 2581052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 10/28/2021; 04/14/2022; 09/10/2022; 12/13/2022; 01/27/2023; 02/09/2023
• Supplement Dates FDA Received: 08/24/2021; 11/01/2021; 04/15/2022; 09/14/2022; 12/22/2022; 02/07/2023; 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2008
• 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; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 52MM; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE MTL INS NEUT36IDX52OD; S-ROM M HEAD 36MM +3; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 18F-XXL; S-ROM*SLEEVE PRX ZTT, 18F-XXL; SROM*STM ST,36+8L NK,18X13X160; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 73 KG