MAUDE Adverse Event Report: ZIMMER GMBH FEMORAL HEAD HIP; N/A

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Medical products and therapy date.Detail of product: item number 00633405028, item name constrained liner with constraining ring use with trilogy and trabecular metal modular acetabular systems 28 mm i.D.For use with 50/52/54 mm o.D.She, lot # 63470106.Item number 00771100710, item name femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 standard offset reduced neck length, lot # 60926658.Item number 00620205022, item name shell porous with cluster holes 50 mm, lot # 00112247.Item number 00620105200, item name 52mm replacement lock ring, lot # 62911635.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Attempts to obtain additional information have been made; however, no more is available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).Item and lot numbers unknown.

Event Description

A patient is pursuing a product liability claim because underwent revision surgery due to pain, elevated metal ions level, acute infection and severe adverse reaction to metal debris.

Manufacturer Narrative

Please note: this follow up has been sent to inform fda about the actual "initial notification date" of this report (may 6, 2020).The initial report for this "winterthur device" has initially been submitted to fda on time by warsaw by mistake.Mfr report number was: 0002648920 - 2019 - 00542.Therefore fda was already informed about this incident on time.(no late report).

Event Description

Please note: this follow up has been sent to inform fda about the actual "initial notification date" of this report (may 6, 2020).The initial report for this "winterthur device" has initially been submitted to fda on time by warsaw by mistake.Mfr report number was: 0002648920 - 2019 - 00542.Therefore fda was already informed about this incident on time.(no late report).

Manufacturer Narrative

Event description: initial right total hip arthroplasty performed (b)(6) 2009.The patient subsequently underwent a revision of the head and liner on (b)(6) 2017 due to recurrent dislocation.The patient then underwent staged revision procedures due to elevated metal ions and continued pain.During the revision, extensive necrosis consistent with adverse reaction to metal debris was noted.The first stage occurred (b)(6) 2017 during which all existing implants were removed, and a depuy spacer was placed with palacos cement.The second stage occurred (b)(6) 2017 to exchange the cement spacer for a new depuy spacer with palacos cement and to remove the cerclage wires.The third stage occurred (b)(6) 2017 during which the spacer was removed and a wagner system was placed.Review of received data: medical records were provided and reviewed by a health care professional.Review of the available records identified the following : the patient underwent an initial right total hip arthroplasty on (b)(6) 2009 due to severe osteoarthritis of left hip.Zimmer biomet products were implanted without complications.The patient underwent a revision procedure on (b)(6) 2016 due to pain and recurrent dislocation.During the revision, the acetabular component was noted to have excessive anteversion, and the joint had extensive connective tissue necrosis.The acetabular shell and femoral stem remained while the head and liner were replaced.The patient then underwent a staged revision procedure in 2017 due to infection, elevated metal ions, and pain.Prior to the procedure, chromium level was 1.2 and cobalt was at 9.7.Stage 1 was on (b)(6) 2017.During stage 1 revision, a thick cream-like purulent material was noted and removed along with huge cavity of dead, necrotic tissue that was consistent with armd.All zimmer biomet products were removed and competitor's cement spacer was placed.During insertion of the spacer, a crack was noted in the femur and two cerclage wires were used to secure the fracture.Stage 2 was on (b)(6) 2017.During stage 2 revision, abundant infected appearing tissue and fluid was noted.Pseudotumor and armd were resected.Stage 3 revision was performed on (b)(6) 2019, during which the wound was irrigated, the prior implants were removed, and new components were placed.There are no other findings related to the reported event.Contributing factors of event: retained m/l taper stem and malpositioned cup from first revision.Product evaluation: no product was returned; therefore, evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: it was reported that the patient underwent an exchange of the head and liner on (b)(6) 2017 due to recurrent dislocation, subsequently, the patient underwent staged revision procedures due to infection, elevated metal ions and continued pain.During the revision, extensive necrosis consistent with adverse reaction to metal debris was noted.The first stage occurred (b)(6) 2017 during which all existing implants were removed based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).The irradiation certificate of the affected lot number could not be reviewed due to missing product identification.However, single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.It remains unknown whether the malpositioned cup which was retained from the first revision surgery might have contributed the elevated metal ion level and reported pain.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation result is available now.

• Brand Name: FEMORAL HEAD HIP
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10055340
• MDR Text Key: 194658589
• Report Number: 0009613350-2020-00216
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention