MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM DISTAL TAPERED 16X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197716190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)
Date of Event	12/26/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).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
Ppf and sticker sheets received.Ppf alleges infection and elevated metal ions.Doi: (b)(6) 2012.Dor: (b)(6) 2012.(left hip).Ppf noted that nothing was removed on this date but a ceramic implant was put in to fill the space created by the removal of the metal implant removed on (b)(6) 2012.This pc is for the second revision of the left hip.See (b)(4) for the first revision.
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 device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Medical records received.On 05/15/2012 pathology report shows several of the fragments are necrotic in appearance, one of the fragments shows chronic inflammatory cells.On (b)(6) 2012, the patient had an extended femoral osteotomy, removal of total hip components including both femoral and acetabular components, implantation of cement spacer with antibiotics to address probable infection in the left hip.Patient was reported to have had pain.Prior to this revision, the patient had several injections to attempt to alleviate the pain with limited success.During this revision surgery, the surgeon observed silver discoloration to the joint fluid.All components were revised due to the probable infection.An extended osteotomy was required to remove the well-fixed femoral stem.(no mention of the manufacturer of the components removed or the components implanted in the current medical records).Cement spacers were placed during this procedure.(b)(4).*on (b)(6) 2012, the patient had a revision of left total hip arthroplasty, reimplantation and finishing of the second stage, to address post infected left total hip arthroplasty.It was noted that the patient had a previous trochanteric osteotomy that had to be reopened and the trochanteric osteotomy had to be replaced after the insertion of the femoral component, with the use of cables.Depuy components were implanted during this procedure, including pinnacle gription cup, altrx liner, apex hole eliminator, biolox delta ts ceramic femoral head, reclaim proximal body, reclaim distal stem and a pinnacle cancellous bone screw.(b)(4).On (b)(6) 2013, there is a new transverse periprosthetic fracture of the left greater trochanter periprosthetic fracture of the left greater trochanter with mild superior displacement of the fracture fragment.Intact bilateral total hip arthroplasties with left proximal femoral cerclage wires.(b)(4).Doi: (b)(6) 2012; dor: unrevised; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
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 that 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.H11 additional narrative: added: a5, b6.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: ppf and sticker sheets received.Ppf alleges infection and elevated metal ions.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) xrays retrieved by ingrid beristain.The x-ray investigation revealed nothing indicative of a device nonconformance at the reclaim distal tapered 16x190a.A manufacturing record evaluation was performed for the finished device product description: reclaim distal tapered 16x190a product code: 197716190 lot number: 282517 and no non-conformances or manufacturing irregularities were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the reclaim distal tapered 16x190a would have not contributed to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.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 description: reclaim distal tapered 16x190a product code: 197716190 lot number: 282517 and no non-conformances or manufacturing irregularities were identified.
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.H11 additional narrative: added: b6, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM DISTAL TAPERED 16X190A
• Common Device Name: RECLAIM IMPLANT : 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: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9341398
• Report Number: 1818910-2019-116886
• Device Sequence Number: 14095546
• Product Code: LZO
• UDI-Device Identifier: 10603295077176
• UDI-Public: (01)10603295077176(17)220831(10)282517
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/23/2019
• 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 Expiration Date: 08/31/2022
• Device Catalogue Number: 197716190
• Device Lot Number: 282517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 05/09/2024; 11/15/2024; 01/07/2025; 07/16/2025; 10/06/2025
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/17/2019; 05/16/2024; 11/28/2024; 01/10/2025; 07/17/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2083-2014
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 NEUT 44IDX62OD.; APEX HOLE ELIM POSITIVE STOP.; CONTROL CABLE W/CABLE SLEEVE.; CONTROL CABLE W/CABLE SLEEVE.; DLT TS CER HD 12/14 44MM +5.0.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN SECTOR W/GRIPTION 62MM.; RECLAIM PRX BDY CONE 20X75.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Hispanic
• Patient Race: White