MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 6IN AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-01-106
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Litigation papers allege the patient sustained serious personal injuries as a result of the hip failing, breaking apart, causing dangerous metals to be released into her body and blood system and causing serious personal injuries.
Additional Manufacturer Narrative
The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
Additional 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, dob), b5, b7, d6a, d10, g1, g2, h6 (clinical, impact and medical device codes).H6 clinical code: appropriate term / code not available (e2402) is used 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 or Problem Description
After review of the medical records, the patient was revised to address failed right tha with mom component with severe metallosis, pseudotumor, elevated metal ions and pain.Cup was slightly vertical on radiographs.Operative note reported large metal debris pseudotumor in the greater trochanter and along the anterior edge of the gluteus medius and throughout the joint.There was metal debris and scar this was excised.Doi: (b)(6) 2009.Dor: (b)(6) 2014.Right hip.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary update 22-sep-2022: 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.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.

• Brand Name: 6IN AML SM STATURE 10.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu IN 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 5396373
• Report Number: 1818910-2016-12173
• Device Sequence Number: 157459
• Product Code: LPH
• UDI-Device Identifier: 10603295058212
• UDI-Public: 10603295058212
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Followup,Followup,Followup
• Report Date (Section B): 01/14/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1554-01-106
• Device Catalogue Number: 155401106
• Device Lot Number: DX5GB1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/14/2021; 05/04/2022; 09/22/2022
• Initial Report FDA Received Date: 01/28/2016
• Supplement Report FDA Received Date: 11/09/2021; 05/06/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5 MM AML FEMORAL; 25 MM X 6.5 ACETABULAR SCREW; 36 MM ULTRA MET HEAD; 36 MM X 50 MM ULTRA MET LINER; 50 MM ACETABULAR CUP; 6IN AML SM STATURE 10.5MM; APEX HOLE ELIM POSITIVE STOP; APEX HOLE ELIMINATOR; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female