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 Code	Unspecified Infection (1930)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Explantation of a reclaim hip-stem left side because of infection.
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.
Event or Problem Description
Surgery and microbiology report received: on (b)(6) 2023 patient had a fall, femoral fracture, pfna nagel depuy/synthes nail implanted.On (b)(6) 2023 left hip diagnosis of sepsis, with no growth noted in pathology report.There was a periprosthetic bone fracture around the nail.Secondary reposition loss in the sense of a nail cut-out after osteosynthesis of pertrochanteric fracture by means of pfna and pain were noted.The wire cages, distal locking screw and nail were removed.The patient was implanted with a hybrid tep with a reclaim distal stem, conical proximal body, and biolox delta ceramic femoral head.It should be noted that no mention of acetabular components being placed during this procedure.(create pc to capture pfna cutout, pain and femur fracture).Do not code for infection as no growth was noted.On (b)(6) 2023 the patient had a revision tep hip joint due to dislocation/joint luxation repositioning of dislocation, in which tissue was collected, which showed infection.There was no loosening noted.(add proximal body and code for infection and head for dislocation (b)(4)).On (b)(6) 2023 patient had a revision replacement of joint socket prosthesis depuy synthes cement cup d20081152 along w tissue removal.Infection was noted.It is unclear if the depuy component listed was revised or implanted.(depuy synthes cemented cup size 46 ref: (b)(4) triloc ii cup 32/46mm).At this time there is no indication of depuy products explanted on (b)(6) 2023.It is believed that depuy cup was placed.Additional follow-up will be conducted to clarify the (b)(6) 2023 event.On (b)(6) 2023, the patient had a revision, change of liner and femoral head along with extensive excision of diseased tissue.Competitor merete bio ball implanted along with bioball metal head were implanted.No mention of cup/stem being revised.This is considered an ongoing infection that has been captured on (b)(4).The cup and liner were placed when there was a known infection, the femoral head and reclaim stem have already been reported for the infection.Unknown date- tep was removed and spacers were inserted.(all components removed) on (b)(6) 2023 (future at the time) spacers to be removed again.Once again, this is an ongoing treatment of a known infection that was captured in (b)(4).
Event or Problem Description
Additional information was received and stated that the removal was due to the nail cut-out from the femoral neck with secondary reposition loss.
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).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: no device associated with this report was received for examination.Bfarm dhr review: product description: reclaim distal tapered 16x190a; product code: 197716190; lot number: m2771g.1) quantity manufactured: (b)(4); 2) date of manufacture: 23-02-2023; 3) any anomalies or deviations identified in dhr: no; 4) expiry date: 31-01-2033; 5) ifu reference: 090200799.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: bfarm dhr review; product description: reclaim distal tapered 16x190a; product code: 197716190; lot number: m2771g.1) quantity manufactured: (b)(4); 2) date of manufacture: 23-02-2023; 3) any anomalies or deviations identified in dhr: no; 4) expiry date: 31-01-2033; 5) ifu reference: 090200799.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : explantation of a reclaim hip-stem left side because of infection.According to the information received, ¿explantation of a reclaim hip-stem left side because of infection.¿ the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that reclaim distal tapered 16x190a found nothing indicative of a device nonconformance or defects that could have contributed to the reported event.A dimensional inspection for the reclaim distal tapered 16x190a was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the reclaim distal tapered 16x190a would not contribute to a device issue.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 depuy synthes 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 : bfarm dhr review, product description: reclaim distal tapered 16x190a, product code: 197716190, lot number: m2771g.1) quantity manufactured: (b)(4), 2) date of manufacture: 23-02-2023, 3) any anomalies or deviations identified in dhr: no, 4) expiry date: 31-01-2033, 5) ifu reference: 090200799.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18231136
• Report Number: 1818910-2023-24266
• Device Sequence Number: 12312777
• Product Code: LZO
• UDI-Device Identifier: 10603295077176
• UDI-Public: 10603295077176
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/29/2023
• 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 Catalogue Number: 197716190
• Device Lot Number: M2771G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 01/02/2024; 01/12/2024; 02/06/2024; 02/14/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/10/2024; 01/14/2024; 02/07/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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: COMPETITOR CUP; COMPETITOR CUP; COMPETITOR HEAD; DELTA CER HEAD 12/14 32MM +5; RECLAIM PRX BDY CONE 20X75; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female